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Part II
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40 CFR Parts 9, 156 and 165
Pesticide Management and Disposal;
Standards for Pesticide Containers and
Containment; Final Rule
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Federal Register / Vol. 71, No. 158 / Wednesday, August 16, 2006 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9, 156 and 165
[EPA–HQ–OPP–2005–0327; FRL–8076–2]
RIN 2070–AB95
Pesticide Management and Disposal;
Standards for Pesticide Containers
and Containment
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: With this final rule, EPA is
establishing regulations for the safe
storage and disposal of pesticides as a
means of protecting human health and
the environment pursuant to the Federal
Insecticide, Fungicide, and Rodenticide
Act. This final rule establishes
requirements for pesticide container
design, and procedures, standards and
label language to facilitate removal of
pesticides from containers prior to
disposal or recycling. This final rule
also establishes requirements for
containment of stationary pesticide
containers and procedures for container
refilling operations. In addition, in order
to display the OMB control number for
the information collection requirements
contained in this final rule, EPA is
amending the table of OMB approval
numbers for EPA regulations that
appears in 40 CFR part 9.
DATES: This final rule is effective on
October 16, 2006. For purposes of
judicial review, this rule shall be
promulgated at 1pm eastern daylight/
standard time on August 30, 2006 (See
40 CFR 23.6).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0327. Please note that the
docket material for the proposed rule
and supplemental notice, identified
previously by docket ID number OPP–
190001, is included as part of the
official docket for this action, although
the material in the legacy docket is
available only in hard copy. All
documents in the docket are listed on
the regulations.gov web site. Although
listed in the index, some information is
not publicly available, e.g., Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either in the
electronic docket at http://
www.regulations.gov, or if only
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available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. The hours
of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Nancy Fitz, Field and External Affairs
Division (7506P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (703) 305–7385; fax number:
(703) 308–2962; e-mail address:
fitz.nancy@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are a pesticide
formulator, agrichemical dealer, or an
independent commercial applicator.
Potentially affected categories and
entities may include, but are not limited
to:
• Pesticide formulators (NAICS
35232, former SIC code 2879), e.g.,
establishments that formulate and
prepare insecticides, fungicides,
herbicides or other pesticides from
technical chemicals or concentrates
produced by pesticide manufacturing
establishments. Some formulating
establishments are owned by the large
basic pesticide producers and others are
independent.
• Agrichemical dealers (NAICS
44422, former SIC code 5191), e.g., retail
dealers that distribute or sell pesticides
to agricultural users.
• Independent commercial
applicators (NAICS 115112, former SIC
code 0721), e.g., businesses that apply
pesticides for compensation (by aerial
and/or ground application) and that are
not affiliated with agrichemical dealers.
• Custom blenders (NAICS 44422,
former SIC code 5191), e.g., most
custom blenders are also dealers.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
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Units II.D., III., V.B., VI.C., VII.B., VIII.C.
and IX.A. of this document. If you have
any questions regarding the
applicability of this action to a
particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the Federal Register listings at
http://www.epa.gov/fedrgstr/. You may
also access a frequently updated
electronic version of the Code of Federal
Regulations (CFR) through the
Government Printing Offices pilot e-CFR
site at http://www.gpoaccess.gov/ecfr/.
II. Background
A. Statutory Authority
These final regulations are issued
pursuant to the authority given the
Administrator of EPA in sections 3, 8,
19 and 25 of the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136a, 136f, 136q and
136w.
Sections 19(e) and (f) of FIFRA grant
EPA broad authority to establish
standards and procedures to assure the
safe use, reuse, storage, and disposal of
pesticide containers. FIFRA section
19(e) requires EPA to promulgate
regulations for the design of pesticide
containers that will promote the safe
storage and disposal of pesticides. The
regulations must ensure, to the fullest
extent practicable, that the containers:
(1) Accommodate procedures used for
removal of pesticides from the
containers and rinsing of the containers.
(2) Facilitate safe use of the
containers, including elimination of
splash and leakage.
(3) Facilitate safe disposal of the
containers.
(4) Facilitate safe refill and reuse of
the containers.
FIFRA section 19(f) requires EPA to
promulgate regulations prescribing
procedures and standards for the
removal of pesticides from containers
prior to disposal. The statute states that
the regulations may:
(1) Specify, for each major type of
pesticide container, procedures and
standards for, at a minimum, triple
rinsing or the equivalent degree of
pesticide removal.
(2) Specify procedures that can be
implemented promptly and easily in
various circumstances and conditions.
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(3) Provide for reuse, whenever
practicable, or disposal of rinse water
and residue.
(4) Be coordinated with requirements
imposed under the Resource
Conservation and Recovery Act (RCRA)
for rinsing containers.
Section 19(f) provides that the EPA, at
the discretion of the Administrator, may
exempt products intended solely for
household use.
Section 19(f)(2) states that after
December 24, 1993, a State may not
exercise primary enforcement
responsibility under section 26, or
certify an applicator under section 11,
unless the Administrator determines
that the State is carrying out an
adequate program to ensure compliance
with regulations promulgated under the
authority of section 19(f)(1).
Section 19(h), titled Relationship to
Solid Waste Disposal Act, specifies that
nothing in section 19 shall diminish the
authorities or requirements of RCRA.
Also, the Food Quality Protection Act
(FQPA) of 1996 amended section 19(h)
of FIFRA to add an exemption for
certain antimicrobial pesticides.
B. Regulatory Background
Prior to 1995, recommendations
regarding procedures for storage and
disposal of pesticides and pesticide
containers were listed under 40 CFR
part 165. On June 19, 1995, as part of
the Federal government’s initiative to
streamline regulations, part 165 was
deleted as unnecessary (60 FR 32094)
because it contained recommendations
rather than requirements. (Ref. 62)
Subpart A of part 165 covered the scope
and definitions in the
recommendations. Subpart B dealt with
EPA’s disposal of suspended and
canceled pesticides, and EPA has
completed disposal of all pesticides for
which it was responsible under those
regulations. Subparts C and D contained
recommended procedures for storage
and disposal of pesticide containers.
Subparts A, B, C, and D were
superseded by the passage of the
Resource Conservation and Recovery
Act in 1976. FIFRA section 19, as
revised in 1988 and 1996, contains
authority for EPA in the area of
pesticide storage and disposal, and the
container and containment regulations
promulgated today are being inserted
into a newly established part 165.
In a Notice of Proposed Rulemaking
(NPRM) issued on February 11, 1994 (59
FR 6712), EPA proposed standards for
pesticide containers and containment
structures. (Ref. 66) This proposal
included requirements for nonrefillable
and refillable containers that would
ensure the safe use and disposal of the
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containers. The proposal also included
standards for containment structures,
which would promote safe storage by
facilitating the safe use, refill, and reuse
of refillable containers. Additionally,
the proposed rule contained
amendments to the labeling regulations
in 40 CFR part 156 to ensure adequate
levels of residue removal from
containers.
The public comment period for the
NPRM closed on July 11, 1994. EPA
received about 1,900 pages of comments
from more than 200 commenters,
including many trade associations and
individual companies from the pesticide
manufacturing, pesticide retail, and
container manufacturing industries as
well as many State regulatory agencies.
EPA received numerous comments on
a few particular issues; specifically the
scope of the container standards and the
relationship between the 1994 proposed
rule and the U.S. Department of
Transportation (DOT) standards for
hazardous materials packaging. A third
issue arose from the 1996 passage of the
FQPA, which amended section 19(h) of
FIFRA to add an exemption for certain
antimicrobial pesticides. To solicit
comment on EPA’s interpretation of the
new statutory language on exempting
antimicrobial pesticides and to reopen
comment on the scope of the container
regulations and an approach for
incorporating DOT’s standards, EPA
published a supplemental notice in the
Federal Register on October 21, 1999
(64 FR 56918). (Ref. 53) The
supplemental notice also provided an
alternative definition of small business
for certain sectors of the pesticide
industry for use in analyzing the
potential impacts to small businesses
that were presented as part of the
economic analysis.
The public comment period for the
supplemental notice closed on March
20, 2000. EPA received comments from
about 70 respondents, including many
trade associations and individual
companies from the pesticide
manufacturing, pesticide retail, and
container manufacturing industries as
well as many State regulatory agencies.
On June 30, 2004 (69 FR 39392), EPA
reopened the public comment period for
this rulemaking for 45 days because
significant time had passed since the
proposed rule in 1994 and supplemental
notice in 1999. (Ref. 33) The purpose of
the reopening was to solicit public input
on any policies, market practices,
technology or other issues relating to
this rule’s requirements which would
not have been available or could not
have been addressed at the time of
either the proposal or supplemental
notice. On August 13, 2004 (69 FR
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50114), the comment period was
extended for 30 days. (Ref. 32) The
public comment period closed on
September 15, 2004. EPA received about
50 comments, mainly from individual
entities or trade associations
representing pesticide manufacturers,
agricultural pesticide retailers and State
regulatory agencies.
On December 17, 1993 (58 FR 65989),
EPA published an interim
determination of adequacy for States
with primary enforcement responsibility
and/or certification programs because
EPA had not promulgated regulations
under section 19(f)(1) by December 24,
1993. (Ref. 69) To avoid having the
provisions of section 19(f)(2) adversely
impact the States and EPA, the Agency
published a policy in the Federal
Register on August 18, 1993 (58 FR
43994), which set forth a process for
EPA to make such an interim
determination. (Ref. 68) EPA’s interim
determination of adequacy was based on
an initial commitment by a State to
conduct a number of activities which
will position the State to have an
adequate program in place by the time
compliance with the regulations
promulgated under section 19(f)(1) is
required. The December 17 notice stated
that the determination of adequacy is
temporary and will expire 2 years after
promulgation of a final rule issued
under section 19(f)(1). Thereafter, States
must have a program to ensure
compliance with the section 19(f)
regulations. Related Federal Register
notices were published on February 25,
1994 (59 FR 9214) regarding New
Mexico and May 10, 1995 (60 FR 24855)
regarding the Virgin Islands. (Refs. 60
and 67) The criteria and process for
evaluating State programs to ensure that
they have adequate compliance
programs for regulations promulgated
under section 19(f) will be published in
a separate Federal Register notice.
C. Additional Container Issues Under
Consideration for Potential Regulation
Since the 2004 public comment
period closed, EPA has gathered
information from a variety of sources
about the status and robustness of
existing pesticide container recycling
programs. Over the past decade, the Ag
Container Recycling Council (ACRC)
has demonstrated that pesticide
containers can be safely and efficiently
recycled, and their success in recycling
more than 80 million pounds of plastic
since 1992 is commendable. However,
the current voluntary container
recycling system is showing signs of
instability and non-sustainability,
largely because it is financially
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supported by only a portion of the
pesticide industry.
EPA has an interest in promoting
recycling to minimize the use of less
environmentally-sound methods of
disposing of these containers, such as by
landfill or burning, and to reduce the
amount of solid waste produced
annually. After considering and
evaluating a number of alternatives to
sustain and increase the current level of
container recycling, EPA has initiated
development of proposed regulations for
the recycling of plastic pesticide
containers to ensure equitable, safe,
effective and robust implementation of
recycling programs. We are exploring a
range of regulatory options for requiring
participation in pesticide recycling
programs and we will work with
stakeholders to evaluate and pursue the
most efficacious of these approaches.
D. Summary of the Final Rule
The Container and Containment Rule
is composed of the following five
specific sets of requirements or
standards:
• Nonrefillable containers (container
design and residue removal);
• Refillable containers (container
design and residue removal);
• Repackaging pesticide products;
• Containment structures; and
• Container labeling.
Table 1 provides a brief overview of
each portion of today’s final rule. For
each section of the regulations, the table
identifies the types of businesses that
must comply, the major requirements
and the compliance date. The
regulations, along with a summary of
comments on major issues and
comments that led to changes to the
final regulations and EPA’s responses,
are discussed in later units of this
preamble. EPA has also prepared a
Response to Comment document that
provides additional details with regard
to the comments and EPA’s responses
(Ref. 19).
Each portion of the regulations
applies to a different subset of pesticide
products. The criteria that define which
pesticide products are subject to which
regulations (and which ones are exempt
from them) are relatively complex, but
some key points are:
• The new label standards apply to
all pesticide products.
• The containment regulations apply
to agricultural pesticides only.
• The nonrefillable container,
refillable container and repackaging
regulations apply to the same subset of
pesticide products. These products are
described in Table 2 below.
• For the refillable container and
repackaging regulations, antimicrobial
products that are used only in
swimming pools (and closely related
sites like hot tubs, spas and/or whirl
pools) are subject to a reduced set of the
requirements.
• For the nonrefillable container
regulations, some products are subject
to all of the regulations, while others
must comply only with the basic
Department of Transportation packaging
requirements in 49 CFR 173.24.
TABLE 1.—OVERVIEW OF THE PESTICIDE CONTAINER AND CONTAINMENT STRUCTURE REGULATIONS
Nonrefillable Containers
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Category
Refillable Containers
Repackaging Pesticide
Products
Container Labeling
Containment Structures
Who must comply
Registrants
Registrants
Refillers (retailers, distributors)
Registrants
Refillers (retailers, distributors)
Registrants
Pesticide users (must
follow new directions)
Ag retailers
Ag commercial applicators
Ag custom blenders
Major Requirements
DOT container design,
construction and
marking standards
Container dispensing
capability
Standardized closures
Residue removal
Recordkeeping
DOT container design,
construction and
marking standards
Serial number marking
One-way valves or
tamper-evident devices
Stationary container
requirements
Registrants develop information
Registrants and others
comply with specified conditions
Refillers (registrants
and others) obtain
and follow registrant
information, and
clean, inspect and
label containers before refilling them
Identify container as
nonrefillable or refillable (all)
Statements to prohibit
reuse and offer for
recycling; batch
code (all
nonrefillables)
Cleaning instructions
(some nonrefillables)
Cleaning instructions
before final disposal
(all refillables)
Secondary containment structures
(dikes) around stationary tanks
Containment pads for
pesticide dispensing
areas
Good operating procedures
Monthly inspections of
tanks and structures
Recordkeeping
Provisions for States
with existing programs
Compliance
Date
August 17, 2009
August 16, 2011
August 16, 2011
August 17, 2009
August 17, 2009
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TABLE 2.—PRODUCTS THAT ARE SUBJECT TO THE NONREFILLABLE CONTAINER, REFILLABLE CONTAINER AND
REPACKAGING REGULATIONS
Category
Nonrefillable Containers
Refillable Containers
Repackaging Pesticide Products
Products that are not
subject to the regulations.
(1) Manufacturing use products,
(2)
Plant-incorporated
protectants, and
(3) Antimicrobial pesticide products that satisfy all four of
these criteria:
The product is an antimicrobial
pesticide (as defined in
FIFRA section 2(mm)) or it
has antimicrobial properties
(as defined in FIFRA section
2(mm)(1)(A)) and is subject
to a tolerance or a food additive regulation.
Its label includes directions for
use on a site in at least one
of the 10 antimicrobial product use categories identified
as household, industrial or
institutional.
It is not a hazardous waste
when it is intended to be disposed, as defined in 40 CFR
part 261.
EPA has not specifically found
that the product must be
subject to these provisions to
prevent an unreasonable adverse effect on the environment.
(1) Manufacturing use products,
(2) Plant-incorporated protectants, and
(3) Antimicrobial pesticide products that
satisfy all four of the criteria listed in
the nonrefillable container column.
(1) Manufacturing use products,
(2) Plant-incorporated protectants, and
(3) Antimicrobial pesticide products that
satisfy all four of the criteria listed in
the nonrefillable container column.
Products that are subject to the regulations
A product is subject to ALL
nonrefillable container requirements if it satisfies at
least one of the following criteria:
It meets the criteria of Toxicity
Category I in 40 CFR
156.62.
It meets the criteria of Toxicity
Category II in 40 CFR
156.62.
It is a restricted use product.
All products not listed above.
All products not listed above.
If a product does not meet any
of these criteria, the product
is subject to only the basic
Department of Transportation
requirements in the nonrefillable container regulations.
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E. Summary of the Major Changes Since
Proposal
1. Plain language format. Many of the
comments on the proposed rule and the
supplemental notice made clear that the
scope of parties and products subject to
the rule was complex and potentially
confusing. We have rewritten the
Container and Containment rule in a
plain language format to make it clearer
and easier to use. A plain language
format includes maximum use of the
active voice; short, clear sentences;
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questions and answers; use of ‘‘you’’ to
identify the person who must comply;
use of ‘‘we’’ to identify EPA; and
‘‘must’’ rather than ‘‘shall.’’ This new
format, which minimizes the layers of
subparagraphs, should also allow the
reader to easily locate specific
provisions of the regulation. While we
have made substantive changes in some
provisions, the plain language changes
are only editorial. The legal
implications of plain English
regulations are the same as traditional
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regulatory text. The word ‘‘must’’
indicates a requirement. Words like
‘‘should,’’ ‘‘could,’’ or ‘‘encourage’’
indicate a recommendation or guidance.
In this preamble, as in the rule text,
we often use the pronoun ‘‘he’’ as a
generic term. ‘‘He’’ does not necessarily
mean a man; it may be a woman, or in
some cases, a business organization
when referring to an owner or operator.
The plain language approach also
leads to more separate sections than
traditional regulatory language.
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Therefore, we had to reorganize and
renumber the regulations to
accommodate the increased number of
separate sections. The changes are
shown in Table 3.
Some sections of today’s regulation
are presented in the traditional language
or format because these sections are
amending or changing existing
regulations. The plain language format
was not used in these existing
provisions in an attempt to avoid any
possible confusion or disruption in the
flow of the regulations.
TABLE 3.—COMPARISON OF PROPOSED RULE AND FINAL RULE SECTION NUMBERS
Format in Proposed Rule
Subpart
Format in Final Rule
Section Numbers
Subpart
Section Numbers
Part 156
Subpart H: Container Labeling
§§ 156.140 - 156.144
Subpart H: Container Labeling
§§ 156.140 - 156.159
Part 165
Subpart A: General
§§ 165.1 - 165.16
Subpart A: General
§§ 165.1 - 165.3
Subpart B
Reserved
Subpart B: Nonrefillable Containers
§§ 165.20 - 165.27
Subpart C
Reserved
Subpart C: Refillable Containers
§§ 165.40 - 165.47
Subpart D
Reserved
Subpart D: Repackaging
§§ 165.60 - 165.70
Subpart E
Reserved
Subpart E: Containment Structures
§§ 165.80 - 165.97
§§ 165.100 - 165.119
Subpart F
Reserved
Subpart G: Refillable Containers
§§ 165.120 - 165.139
Subpart G
Reserved
Subpart H: Containment Structures
§§ 165.140 - 165.157
Subpart H
Reserved
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Subpart F:
tainers
Nonrefillable
Con-
2. Reorganization of the rule. In the
final rule, we split the refillable
container standards and the repackaging
standards into two separate subparts to
reinforce and clarify the differences
between these requirements. The
refillable container regulations are
mostly technical and apply mostly to
pesticide registrants. On the other hand,
the repackaging requirements are mostly
procedural and apply to registrants and
refillers (who could be registrants,
distributors or retailers). EPA believes
that separating these regulations into
different subparts will better illustrate
the differences and make it easier for the
regulated parties to understand.
3. Scope of products subject to
container-related regulations. In the
February 1994 NPRM, EPA proposed
that the container standards would
generally apply to all pesticides and all
containers except for manufacturing use
products (MUPs). The 1999
supplemental notice proposed several
options for exempting specific subsets
of products from the container
standards. Today’s final rule exempts
MUPs, plant-incorporated protectants
and certain antimicrobial products from
the nonrefillable container, refillable
container and repackaging regulations.
All other products are subject to the
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container-related regulations, although
the number of applicable standards is
greatly reduced for some products.
These changes apply only to the
container-related sections of the rule. As
we proposed, all pesticide products are
subject to the container labeling
requirements in today’s final rule and
only agricultural pesticide products are
subject to the containment
requirements.
4. Exemption from container-related
regulations for certain antimicrobial
products. The FQPA amended section
19 of FIFRA to exempt certain types of
antimicrobial pesticides from the
pesticide container provisions. The
amendment exempted household,
industrial, or institutional antimicrobial
products which are not subject to the
Solid Waste Disposal Act (SWDA) from
the container regulations unless the EPA
Administrator determines that the
product causes an unreasonable adverse
effect on the environment. Because the
definition of an antimicrobial product is
complex, the phrase ‘‘subject to the
SWDA’’ is unclear and ‘‘unreasonable
adverse effects on the environment’’
from pesticide containers need to be
clarified, EPA conducted many analyses
based on the comments received.
According to today’s final rule, an
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antimicrobial product is exempt from
the container standards if meets all four
of the following criteria:
• The product is an antimicrobial
pesticide as defined in FIFRA section
2(mm) or it has antimicrobial properties
(as defined in FIFRA section
2(mm)(1)(A)) and is subject to a
tolerance or a food additive regulation.
• The product includes directions for
use on a site in one of the antimicrobial
product use categories identified as
household, industrial or institutional.
• The product is not a hazardous
waste when it is intended to be
disposed.
• EPA has not specifically
determined that the product must be
subject to the container regulations to
prevent an unreasonable adverse effect
on the environment.
In addition, antimicrobial products that
would not otherwise be exempt from the
regulations and that are used only in
swimming pools (and closely related
sites like hot tubs, spas and/or whirl
pools) are subject to a reduced set of the
refillable container and repackaging
requirements.
5. Scope of container-related
regulations for products other than
antimicrobial products. As proposed in
1994, MUPs are exempt from the
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container regulations. Plantincorporated protectants, which were
not discussed in the proposed rule, are
also exempt from the container
regulations. According to today’s final
rule, all other pesticide products, except
antimicrobial pesticides that are
exempt, are subject to the nonrefillable
container, refillable container and
repackaging regulations. For the
nonrefillable container regulations, a
product is subject to all of the
requirements if it classified in at least
one of the following categories:
• Toxicity Category I;
• Toxicity Category II;
• Restricted use pesticide.
Products that do not meet at least one
of these criteria (i.e., products that are
classified in Toxicity Category III or IV
and that are not restricted use
pesticides) are excluded from all of the
nonrefillable container standards except
the basic DOT requirements.
In general, products other than MUPs,
plant-incorporated protectants and
exempt antimicrobial products are
subject to all of the refillable container
and repackaging regulations. One
exception is that antimicrobial products
that are used only in swimming pools
and closely related sites are subject to a
reduced set of the refillable container
and repackaging requirements.
6. Referring to and adopting some
Department of Transportation
regulations. In the 1994 proposed rule,
EPA clarified that compliance with
EPA’s container regulations would not
exempt registrants from complying with
applicable DOT Hazardous Materials
Regulations, and that compliance with
DOT’s marking and drop test
requirements would satisfy the
corresponding EPA requirement for
refillable containers. Also, the preamble
of the proposed rule requested comment
on several options for determining who
would be responsible for ensuring that
containers meet the standards. In the
1999 supplemental notice, we discussed
the comments on the proposal and
discussed a new approach, namely to
adopt and refer to the DOT Packing
Group III criteria for both nonrefillable
and refillable containers. Today’s final
rule includes the same basic approach
as described in the supplemental notice.
Specifically:
• Pesticide products that are DOT
hazardous materials must be packaged
as required by DOT.
• Pesticide products that are not DOT
hazardous materials must be packaged
in containers that are designed,
constructed, and marked to comply with
the cross-referenced and adopted
requirements of DOT regulations, as
applicable to a Packing Group III
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material or the limited quantity/
consumer commodity exception.
• All pesticide products must comply
with the pesticide-specific requirements
in the nonrefillable and refillable
container regulations.
• EPA may modify or waive these
requirements under certain, limited
conditions.
• If DOT proposes to change any of
the regulations that are incorporated by
these regulations, EPA will provide
notice to the public in the Federal
Register.
7. Residue removal standard for
nonrefillable containers. The 1994
NPRM required that registrants
demonstrate at least 99.9999 (six 9’s)
percent residue removal using a
prescribed testing methodology for
dilutable products in rigid containers.
Testing would have been required on 19
representative samples in accordance
with Good Laboratory Practice (GLP)
standards in 40 CFR part 160. We
received many comments opposing
virtually every aspect of this proposed
requirement. Today’s final rule requires
rigid containers of dilutable liquid
formulations to be capable of achieving
at least 99.99 percent (four 9’s) residue
removal using a defined laboratory
triple rinse method conducted on three
representative containers. In addition,
testing and recordkeeping is only
required for flowable concentrate
formulations or if EPA requests the tests
on a case-by-case basis.
8. Consistency with existing State
containment regulations. At least 19
States have already promulgated and
implemented State bulk containment
regulations. EPA’s proposed rule
included basic standards generally
similar to State standards, although
some were more rigorous and others less
stringent than certain State standards.
Today’s containment standards are
intended to introduce substantial
safeguards in States that currently lack
containment regulations and to
harmonize with containment
requirements in States where adequate
containment safety programs already
exist. While EPA believes a national
standard must provide substantial
environmental protection, a mechanism
is being provided to accommodate
States that have successfully
implemented bulk containment
programs.
9. Hydraulic conductivity standard for
containment structures. The proposed
rule would have required that existing
and new structures demonstrate
compliance with a hydraulic
conductivity standard of 1 x 10-6 cm/sec
and 1 x 10-7 cm/sec, respectively. EPA
received many comments opposed to
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the hydraulic conductivity standard
which was perceived to be too
restrictive, not achievable and too
costly. The requirement for a numeric
hydraulic conductivity standard was
dropped from the final rule, but all
existing and new structures are required
to be liquid-tight, with cracks and seams
sealed.
10. Scope of products subject to label
regulations. The final labeling
regulations in today’s rule cover the
same statements and topics that were
included in the proposed rule. Unlike
the container-related regulations, all
products must comply with the
container labeling requirements — the
labeling regulations do not exempt
MUPs or certain antimicrobial products.
One exception is that plant-incorporated
protectant container-related labeling
instructions will be determined by EPA
on a case-by-case basis until specific
labeling guidance for plant-incorporated
protectants are promulgated under 40
CFR part 174.
While today’s label requirements
generally apply to all pesticide
products, the specific label
requirements apply to different groups
of products and containers. In
particular:
• A statement identifying a container
as nonrefillable or refillable is required
on the labels of all products and all
containers.
• Statements to prohibit reuse and
offer for recycling and a batch code are
required on the labels or container of all
products distributed or sold in
nonrefillable containers.
• Rinsing instructions are required on
the labels of some products distributed
or sold in nonrefillable containers.
Specifically, the requirement for rinsing
instructions applies to dilutable
products in rigid nonrefillable
containers. Residential/household use
pesticide products are exempt from this
requirement.
• Instructions for cleaning before
final disposal (not before refilling) are
required on the labels of all products
distributed or sold in refillable
containers.
III. Container Regulations—Scope
The purpose of Unit III. is to describe
the scope of the container-related
regulations, including the standards for
nonrefillable containers in 40 CFR part
165, subpart B, refillable containers in
subpart C and repackaging pesticide
products in subpart D. The regulations
themselves are discussed in more detail
in Units V., VI. and VII. for nonrefillable
containers, refillable containers and
repackaging, respectively. Unit IV.
discusses the relationship between
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EPA’s container-related regulations and
the Department of Transportation’s
Hazardous Materials Regulations.
EPA is exempting some pesticides
and containers from today’s rule based
on the statutory language and the
relative risk posed by the pesticides and
containers. The 1994 NPRM proposed
that the container regulations would
generally apply to all end use pesticides
and all containers, regardless of the
pesticide market sector. The NPRM
proposed to exempt MUPs from the
container requirements. Many
commenters opposed the broad scope of
the regulations and requested EPA to
exempt one or more subsets of
pesticides from the container
requirements.
The 1996 FQPA amended section 19
of FIFRA to exempt certain types of
antimicrobial pesticides from the
container provisions under certain
circumstances. In the October 1999
Supplemental Notice, EPA proposed a
regulatory option for exempting certain
pesticides, and requested comment on
the applicability and interpretation of
the antimicrobial exemption to FIFRA.
As described in this unit, the
container-related provisions in the final
rule apply only to a subset of end use
pesticide products. All MUPs and plantincorporated protectants are exempt
from the container-related requirements.
The container regulations define criteria
for antimicrobial products that are
subject to the container-related
standards. Other than MUPs, plantincorporated protectants and exempt
antimicrobial products, all products are
subject to the nonrefillable container,
refillable container and repackaging
regulations. However, some products
are subject to a reduced number of
requirements. The discussion in Unit III.
applies only to the nonrefillable
container, refillable container and
repackaging regulations. The
containment and labeling regulations
have different scopes, as described in
Units VIII. and IX.
A. Exempt Manufacturing Use Products
(§§ 165.23(a), 165.43(a) and 165.63(a))
1. Final regulations. MUPs, as defined
in 40 CFR 158.153(h), are exempt from
the container regulations. As described
in the preamble to the proposed rule,
this exemption applies to technical
grade products and formulation
intermediates intended only for
formulation into other pesticide
products and labeled for formulation
use only.
2. Changes. This exemption is
identical to the exemption in the 1994
proposed rule and the 1999
Supplemental Notice.
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B. Exempt Plant-Incorporated
Protectants (§§ 165.23(b), 165.43(b) and
165.63(b))
1. Final regulations. Plantincorporated protectants, as defined in
40 CFR 174.3, are exempt from the
container regulations.
2. Changes. EPA did not specifically
mention plant-incorporated protectants
in either the proposed rule or the
supplemental notice because there were
either no registrations for these products
or they were uncommon at that time;
these types of products are relatively
new to the marketplace. In the June 30,
2004 Federal Register notice (69 FR
39393), EPA cited plant-incorporated
protectants as an example of a topic that
would be appropriate to comment on
during the 2004 reopening of the
comment period. (Ref. 33) As explained
below, EPA believes it is appropriate to
exempt plant-incorporated protectants
from the container requirements in the
final rule.
In comments on the 2004 Federal
Register notice, two registrant groups
and five registrants urged EPA to
exempt plant-incorporated protectants
from the container and containment
regulations. These commenters stated
that plant-incorporated protectants fit
the three conditions of EPA’s treated
article policy and therefore should be
exempt from all provisions of FIFRA
when used in the manner described.
They also concurred with EPA’s
assessment in the 2004 Federal Register
notice that plant-incorporated
protectants are not sold and distributed
in containers like other pesticides; they
are distributed as parts of seeds or
plants.
The regulations for plant-incorporated
protectants in 40 CFR parts 152 and 174
were finalized in the Federal Register
on July 19, 2001 (66 FR 37771). (Ref. 50)
A plant-incorporated protectant is a
pesticidal substance that is intended to
be produced and used in a living plant,
or in the produce thereof, and the
genetic material necessary for
production of such a pesticidal
substance. As explained in the preamble
to the final rule for plant-incorporated
protectants (66 FR 37774), ‘‘[p]lantincorporated protectants are primarily
distinguished from other types of
pesticides because they are intended to
be produced and used in a living plant.
This difference in use pattern dictates in
some instances differences in
approach.’’ (Ref. 50) Plant-incorporated
protectants are not sold and distributed
in containers as distinct substances (e.g.,
liquids, solids or gels) like other
pesticides; they are distributed as part of
the seeds or plants. In other words,
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plant-incorporated protectants do not
have containers like most pesticides.
Therefore, EPA believes it is appropriate
to exempt plant-incorporated
protectants from the requirements of the
container-related regulations.
C. Exempt Certain Antimicrobial
Products (§§ 165.23(c), 165.43(c) and
165.63(c))
The 1996 FQPA amended section 19
of FIFRA to exempt certain types of
antimicrobial pesticide products from
the pesticide container provisions under
certain circumstances. Specifically,
FQPA added the following to FIFRA
section 19(h):
A household, industrial, or institutional
antimicrobial product that is not subject to
regulation under the Solid Waste Disposal
Act (42 U.S.C. 6901 et seq.) shall not be
subject to the provisions of subsections (a),
(e), and (f), unless the Administrator
determines that such product must be subject
to such provisions to prevent an
unreasonable adverse effect on the
environment.
Because this language was added after
the pesticide container and containment
rule was proposed in 1994, EPA
solicited public comment on the
applicability of this provision to the
proposed container regulations in the
1999 supplemental Federal Register
notice. In addition, the supplemental
notice described EPA’s interpretation
and response to the following two broad
questions relating to the antimicrobial
exemption provision:
• What is the scope of household,
industrial, or institutional antimicrobial
products that are not subject to
regulation under the Solid Waste
Disposal Act?
• Which products must be subject to
the container provisions to prevent an
unreasonable adverse effect on the
environment?
Based on comments on the proposed
rule and supplemental notice and on
several additional analyses, EPA is
making a number of changes in the
approach for regulating antimicrobial
products in the final regulations. The
approach in the final rule is briefly
described here and the details are
provided in the issue-by-issue sections
below.
• All four of the following criteria
must be met for a product to be exempt
from the container regulations:
(1) The product is an antimicrobial
pesticide as defined in FIFRA section
2(mm) or it has antimicrobial properties
(as defined in FIFRA section
2(mm)(1)(A)) and is subject to a
tolerance or a food additive regulation.
(2) The product includes directions
for use on a site in one of the
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antimicrobial product use categories
identified as household, industrial or
institutional.
(3) The product is not a hazardous
waste when it is intended to be
disposed.
(4) EPA has not specifically
determined that the product must be
subject to the container regulations to
prevent an unreasonable adverse effect
on the environment.
• EPA will determine which products
must be subject to the container
provisions to prevent an unreasonable
adverse effect on the environment on a
case-by-case basis as described in the
regulations.
• The final rule exempts refillable
containers used to distribute
antimicrobials used in swimming pools
(and that are subject to the regulations
because they do not meet all of the
exemption criteria) from some of the
refillable container and repackaging
standards (including, but not limited to,
serial number markings, one-way valves
or tamper-evident devices, and some
recordkeeping).
The four criteria that identify which
antimicrobial products are exempt from
the container regulations are discussed
in greater detail in Units III.C.1. - III.C.4.
The other aspects of the approach
toward regulating antimicrobials are
discussed in Units III.D. - III.F.
Throughout the preamble, the term
‘‘antimicrobial’’ is intended to be
interpreted broadly with the property of
destroying or inhibiting the growth of
microorganisms (and as identified in
FIFRA section 2(mm)(1)(A)) unless
specified otherwise. In other words, we
specify ‘‘FIFRA 2(mm) antimicrobial
pesticides’’ if we are referring to the
more limited definition of antimicrobial
pesticides in FIFRA section 2(mm).
1. Exemption criteria: definition of an
antimicrobial pesticide—i. Final
regulations. The first of the four criteria
that must be met for an antimicrobial
product to be exempt from the container
regulations is:
The pesticide product meets one of
the following two criteria:
(1) The pesticide product is an
antimicrobial pesticide as defined in
FIFRA section 2(mm); or
(2) The pesticide product:
(i) Is intended to: disinfect, sanitize,
reduce or mitigate growth or
development of microbiological
organisms; or protect inanimate objects,
industrial processes or systems,
surfaces, water, or other chemical
substances from contamination, fouling,
or deterioration caused by bacteria,
viruses, fungi, protozoa, algae, or slime;
and
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(ii) In the intended use is subject to
a tolerance under section 408 of the
Federal Food, Drug, and Cosmetic Act
or a food additive regulation under
section 409 of such Act.
ii. Changes. In the supplemental
notice, this criterion was limited to
‘‘The product meets the definition of an
antimicrobial pesticide in FIFRA section
2(mm).’’ EPA continues to believe that
the most straightforward approach for
defining antimicrobial products is to use
the FIFRA definition of antimicrobial
pesticide. The second criterion was
added because, after thorough analysis
of the definition of antimicrobial
pesticide, EPA believes that some
pesticides that are excluded from the
definition should be eligible for
exemption from the container
regulations. Specifically, FIFRA section
2(mm)(1)(B) explicitly excludes
pesticides with antimicrobial properties
as identified in section 2(mm)(1)(A)
from being FIFRA section 2(mm)
antimicrobial pesticides if they are
subject to a tolerance or a food additive
regulation in their intended use. EPA
believes that these pesticides should be
eligible for exemption from the
container regulations along with
pesticides that are FIFRA section
2(mm)-defined antimicrobial pesticides.
Although there is no official
legislative history documenting the
intent of the definition of antimicrobial
pesticide in FQPA, EPA acknowledges
that FQPA also established time periods
in FIFRA section 3 for registration
review and action for various kinds of
antimicrobial pesticides. EPA believes it
is reasonable to conclude that pesticides
subject to a tolerance or food additive
regulation were excluded from the
FIFRA section 2(mm) definition of
antimicrobial pesticide at least partly
because these pesticides require more
data and analysis than other
antimicrobial pesticides and, therefore,
should not be subject to the registration
time periods established in FIFRA
section 3.
More importantly, EPA believes that
the containers of pesticides with
antimicrobial properties that are subject
to a tolerance or food additive
regulation generally pose a limited risk
to human health and the environment.
If either EPA or the Food and Drug
Administration (FDA) determine that a
pesticide with antimicrobial properties
can be safely used on food or on food
contact surfaces, the containers holding
these pesticides are unlikely to pose a
significant risk or even a risk greater
than the pesticides that are FIFRA
2(mm) antimicrobial pesticides. EPA
believes that these pesticides should
also be eligible for exemption from the
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pesticide container regulations and that
exempting these pesticides should not
significantly increase the risk posed by
containers of these pesticides.
Therefore, it is very unlikely that such
an exemption would pose an
unreasonable adverse effect on the
environment. We believe the provisions
of FIFRA sections 19 and 25 authorize
such an exemption.
While EPA is identifying pesticides
with antimicrobial properties that are
subject to a tolerance or food additive
regulation as being eligible for
exemption from the container
regulations, they are not automatically
exempt. Pesticides with antimicrobial
properties that are subject to a tolerance
or food additive regulation must also
meet the other criteria identified by
Congress in the FIFRA section 19(h)
language: (1) It is a household,
industrial or institutional product; (2) it
is not a hazardous waste when
disposed; and (3) EPA has not
determined it must be subject to the
regulations to prevent an unreasonable
adverse effect. While EPA believes it is
reasonable to make pesticides with
antimicrobial properties that are subject
to a tolerance or food additive
regulation eligible for exemption from
the pesticide container regulations, we
see no reason that these pesticides
shouldn’t be subject to the other criteria
that Congress established for
antimicrobial pesticides.
EPA is not implementing similar
exemption provisions for the other
pesticide types excluded from the
definition of antimicrobial pesticide in
FIFRA section 2(mm), which include:
• Wood preservatives with claims for
pests other than micro-organisms;
• Antifouling paint products with
claims for pesticides other than microorganisms;
• Agricultural fungicide products;
and
• Aquatic herbicide products.
EPA does not believe that the
pesticides in this list generally pose a
limited risk to human health and the
environment, as is the case with
pesticides with antimicrobial properties
that are subject to a tolerance or food
additive regulation. EPA analyzed one
of its pesticide data bases (Reference
File System or REFS) and identified the
wood preservative and antifouling paint
products that claim to control pests
other than micro-organisms. Many of
the wood preservative products that
claim to control pests other than microorganisms also would be hazardous
wastes when they are disposed and
many of these are also restricted use
products, such as those containing
arsenic acid, arsenic pentoxide, chromic
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acid, coal tar, creosote and
pentachlorophenol. Many of the
antifouling paint products that claim to
control pests other than microorganisms are also restricted use
pesticides, such as products containing
copper (I) oxide, bis(tributyltin oxide)
and tributyltin methacrylate. EPA does
not believe that products containing
these active ingredients meet the
criterion of generally posing a limited
risk to human health and the
environment, as is the case with
pesticides with antimicrobial properties
that are subject to a tolerance or food
additive regulation.
2. Exemption criteria: household,
institutional or industrial products—i.
Final regulations. The second of four
criteria that must be met for an
antimicrobial product to be exempt from
the container regulations is:
The product includes directions for
use on a site in one of the following 10
antimicrobial product use categories
identified as ‘‘household, industrial or
institutional:’’
(1) Food handling/storage
establishments premises and
equipment.
(2) Commercial, institutional, and
industrial premises and equipment.
(3) Residential and public access
premises.
(4) Medical premises and equipment.
(5) Human drinking water systems.
(6) Materials preservatives.
(7) Industrial processes and water
systems.
(8) Antifouling coatings.
(9) Wood preservatives.
(10) Swimming pools.
ii. Changes. Prompted by comments
and after re-evaluating the antimicrobial
product use categories, EPA is
modifying the approach in the
supplemental notice by adding a tenth
category, human drinking water
systems, to the list of ‘‘household,
industrial or institutional’’ uses. EPA
agrees with commenters that the
category of human drinking water
systems includes use in individual
water systems, which could be used in
homes. Additionally, human drinking
water systems include use in public
water systems and the drinking water
treatment facilities that use the
pesticides for this purpose fit into a
reasonable understanding of industrial
use. Therefore, 10 of the 12
antimicrobial product use categories
will be ‘‘household, industrial or
institutional’’ uses, compared to the
nine categories identified in the
supplemental notice. The two
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antimicrobial product use categories
that are not identified as ‘‘household,
industrial or institutional’’ are
‘‘agricultural premises and equipment’’
and ‘‘aquatic areas.’’ Multiple-use
products with labels that include
directions for use on a site in one of the
excluded categories (‘‘agricultural
premises and equipment’’ and ‘‘aquatic
areas’’) and in at least one of the ten
antimicrobial use product categories
identified as ‘‘household, industrial and
institutional’’ would be eligible for
exemption.
3. Exemption criteria: not subject to
RCRA—i. Final regulations. The third of
four criteria that must be met for an
antimicrobial product to be exempt from
the container regulations is:
The pesticide product is not a
hazardous waste as set out in 40 CFR
part 261 when the pesticide product is
intended to be disposed.
ii. Changes. This criterion is nearly
the same as in the supplemental notice,
but EPA modified the language slightly
in response to a few comments to clarify
that antimicrobials that are household
waste are eligible for exemption. Rather
than specifying that ‘‘the pesticide
product does not meet the criteria for
hazardous waste as set out in part
261...’’ as discussed in the supplemental
notice, the final rule uses broader
language (‘‘the pesticide product is not
a hazardous waste as set out in part
261...’’) that clearly includes all of the
criteria, exclusions and other provisions
in 40 CFR part 261.
4. Exemption criteria: EPA has not
specifically determined the product
must be subject to the regulations—i.
Final regulations. The fourth of four
criteria that must be met for an
antimicrobial product to be exempt from
the container regulations is that EPA has
not specifically determined that the
pesticide product must be subject to the
regulations to prevent an unreasonable
adverse effect on the environment
according to the provisions discussed in
Unit III.F.
ii. Changes. This criterion is
necessary to implement Option 1 in the
supplemental notice. The sample
regulatory text in the supplemental
notice did not specifically have a
provision for subjecting antimicrobial
products to the container regulations on
a case-by-case basis because the sample
regulatory text reflected Option 3. As
discussed in Unit III.F, the final rule
must define conditions and procedures
for EPA to determine that an
antimicrobial product or group of
products must be subject to the
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container regulations to prevent an
unreasonable adverse effect on the
environment. Because EPA may subject
certain antimicrobial products to the
container regulations in the future, a
fourth criterion is necessary for the list
of criteria for the antimicrobial products
that are exempt from the container
regulations. Respondents provided
extensive comments (described in Unit
III.E.) about how EPA should make
these determinations.
D. Antimicrobial Swimming Pool
Products That Are Not Exempt
(§§ 165.43(d), 165.63(d))
1. Final regulations. An antimicrobial
swimming pool product that is not
otherwise exempt (because it is a
manufacturing use product, plantincorporated product or an exempt
antimicrobial product) is subject to a
reduced set of the refillable container
and repackaging regulations. Comments
on the supplemental notice and an
analysis of antimicrobial products
indicated that some antimicrobial
swimming pool products are hazardous
wastes when they are disposed and,
therefore, would be subject to the
pesticide container regulations because
they do not meet all four criteria for
exemption.
For the purposes of subparts C and D,
an antimicrobial swimming pool
product is a pesticide product that
satisfies both of the following
conditions:
• The pesticide product is intended
to: disinfect, sanitize, reduce or mitigate
growth or development of
microbiological organisms; or protect
inanimate objects, industrial processes
or systems, surfaces, water, or other
chemical substances from
contamination, fouling, or deterioration
caused by bacteria, viruses, fungi,
protozoa, algae, or slime.
• The labeling of the pesticide
product includes directions for use only
on a site or sites in the antimicrobial
product use category of swimming
pools.
Antimicrobial swimming pool
products that are not exempt must
comply with all of the refillable
container regulations in subpart C
except for:
• § 165.45(d) regarding marking; and
• § 165.45(e) regarding openings.
Antimicrobial swimming pool
products that are not exempt must
comply with all of the repackaging
regulations in subpart D except for the
following requirements:
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Requirement
Requirement for registrants who distribute or sell directly in refillable containers
Requirement for refillers who are not registrants
Recordkeeping specific to
each instance of repackaging
§ 165.65(i)(2)
§ 165.70(j)(2)
Container inspection: criteria regarding a serial
number or other identifying code
§ 165.65(e)(3)
§ 165.70(f)(3)
Container inspection: criteria regarding one-way
valve or tamper-evident
device
§ 165.65(e)(4)
§ 165.70(f)(4)
Cleaning requirement: criteria regarding one-way
valve or tamper-evident
device
§ 165.65(f)(1)
§ 165.70(g)(1)
Cleaning if the one-way
valve or tamper-evident
device is not intact
§ 165.65(g)
§ 165.70(h)
2. Changes. The supplemental notice
included a similar provision, but it
would have applied only to products
eligible for exemption. Based on the
comments and further analysis, EPA
realized that the products for which
relief was intended (those with sodium
hypochlorite) may be hazardous wastes
when disposed and, therefore, would
not be eligible for either full or partial
exemption according to the approach in
the supplemental notice. Today’s final
rule subjects antimicrobial swimming
pool products to a reduced set of the
refillable container and repackaging
requirements if they are sold and
distributed in refillable containers.
Specifically, antimicrobial swimming
pool products would not have to
comply with some of the standards,
including, but not limited to, serial
number markings, one-way valves or
tamper-evident devices, and some
recordkeeping. Currently, EPA is aware
of sodium hypochlorite products that fit
these criteria and that are sold and
distributed in refillable containers.
However, the partial exemption was
drafted to be general so it would apply
to any products that fit the criteria.
A description of an antimicrobial
swimming pool product was added to
subparts C and D for clarity. The
regulatory text was modified to clarify
that the reduced set of requirements
applies to products labeled for use on a
site or sites only in the antimicrobial
product use category of swimming pools
(which includes swimming pools, spas,
hot tubs, and whirlpools). In other
words, a product that is labeled for use
in swimming pools (and/or spas, hot
tubs and whirlpools) and another site,
such as human drinking water systems,
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would have to comply with the full set
of refillable container and repackaging
requirements. Alternatively, the
registrant of such a product could
remove the use site(s) other than those
in the antimicrobial product use
category of swimming pools from the
label, in which case the product would
be subject to the reduced set of refillable
container and repackaging
requirements.
Many antimicrobial swimming pool
products are completely exempt from
the nonrefillable container, refillable
container and repackaging regulations
by §§ 165.23(c), 165.43(c) and 165.63(c).
However, some antimicrobial swimming
pool products are subject to the
container-related regulations because
they do not meet all of the criteria in
these sections, for example, because
they are hazardous wastes when they
are disposed. The partial exemption in
§§ 165.43(d) and 165.63(d) provides
some regulatory relief from the refillable
container and repackaging requirements
for such antimicrobial swimming pool
products. Antimicrobial swimming pool
products that are not completely exempt
must comply with all of the
nonrefillable container requirements.
E. EPA Determinations that Products
Must be Subject to the Container
Regulations to Prevent an Unreasonable
Adverse Effect on the Environment
1. Final regulations. The final
regulations exempt all antimicrobial
products that are eligible for exemption
according to the criteria described in
Unit III.C. from needing to comply with
the nonrefillable container, refillable
container and repackaging regulations.
The final regulations also include a
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provision that allows EPA to determine,
on a case-by-case basis, that a specific
product or group of products must be
subject to the regulations to prevent an
unreasonable adverse effect on the
environment if a problem becomes
evident. The specifics of this provision
are discussed in Unit III.F.
2. Changes. The approach in the final
rule is a change from the approach that
was identified as our preferred approach
(Option 3) in the supplemental notice,
which would have subjected all
antimicrobials eligible for exemption
that were classified in Toxicity Category
I to a subset of the container regulations.
In the supplemental notice, EPA
described four options for determining
which antimicrobial products that are
eligible for exemption would be subject
to the container provisions to prevent an
unreasonable adverse effect on the
environment. Today’s final rule
establishes Option 1 as the procedure to
be implemented, which exempts all
eligible antimicrobials, but includes a
provision to require a specific product
or group of products to comply with the
container regulations if a problem
becomes evident. The four options in
the supplemental notice were:
• Option 1: Exempt all eligible
antimicrobials, but include a provision
to require a specific product or group of
products to comply with the container
regulations if a problem becomes
evident.
• Option 2: Subject eligible
antimicrobials classified in Toxicity
Category I to all of the container
regulations.
• Option 3: Subject eligible
antimicrobials classified in Toxicity
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Category I to a subset of the container
regulations.
• Option 4: Apply the scope criteria
being considered for other pesticides to
eligible antimicrobials.
3. Comments. Two state agencies
supported EPA’s approach in the
supplemental notice (Option 3).
Eighteen commenters, representing the
antimicrobial and/or the swimming
pool/spa industries, strongly opposed
EPA’s approach, and most supported
Option 1. An agricultural registrant
stated that the language in section 19(h)
is not a blanket exemption, and that
focusing on only Toxicity Category I (as
opposed to Toxicity Categories I and II
in the applicability for all other
products) is unfair and inconsistent.
Many commenters opposed EPA’s
approach and supported Option 1,
either by specifically identifying it as
the option EPA should adopt or by
describing and supporting an approach
that is consistent with Option 1. These
commenters supported their positions
with the following claims:
i. Statutory intent. Some commenters
stated that only Option 1 is consistent
with the statutory language. Several
respondents specifically disagreed with
EPA’s general criteria approach, saying
it was unnecessary, inappropriate and
inconsistent with the statutory language.
ii. Congress’s intent. Similarly, many
commenters stated that only Option 1 is
consistent with Congress’s intent. The
commenters generally argued that
Congress’s clear intent was to exempt
nearly all eligible antimicrobials. One
commenter referred to testimony
received and comments made at various
committee hearings to support its
interpretation of the congressional
intent. Several commenters stated that
EPA’s approach is contrary to the
position of EPA negotiators during preFQPA discussions, which was that the
provision constituted essentially a
complete exemption.
iii. No information about
unreasonable adverse effects. Many
respondents pointed out that EPA does
not have concrete information, such as
documented incidents, of unreasonable
adverse effects (UAEs) caused by
antimicrobial pesticides. In addition,
several pool supply companies said that
there are no reports of accidents with
refillable containers used for pool
chemicals and mentioned that they have
used these containers safely for many
years and for large volumes of sodium
hypochlorite.
iv. Standard of unreasonable adverse
effect on the environment. Several
commenters stated that the process of
registration is intended to ensure that
the pesticide will not cause an UAE,
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and therefore all registered products,
including those in Toxicity Category I,
have been determined to meet a
standard of no UAE. These commenters
further argued that information on
specific exposures, leakage or other
problems is needed to overturn the
registration decision of no UAE and to
determine that an UAE must be
prevented. Another respondent
commented that Congress didn’t
provide additional insight into what
constitutes an UAE in the context of
section 19, so it must have the same
meaning as in the FIFRA registration
standard in section 3(c)(5) and the
obligation to report information on UAE
in section 6(a)(2).
v. FIFRA section 6(a)(2) reporting.
Several commenters stated that the
section 6(a)(2) obligation for registrants
to submit factual information regarding
UAE to EPA provides an adequate
mechanism for EPA to identify UAEs
caused by antimicrobials eligible for
exemption. A few of these respondents
pointed out that the UAE standard in
section 6(a)(2) is exactly the same as the
standard in section 19(h)(2).
vi. Minimal threat to the environment.
Several commenters specifically
addressed sodium hypochlorite and
commented that it is not a threat to the
environment because: it has a short half
life; it’s final fate is sodium chloride
(table salt); it is used widely without
evidence that it is problematic; it’s only
in Toxicity Category I for eye effects,
unlike the toxic and persistent
agricultural pesticides; it’s an inorganic
chemical; the institutional/industrial
formulation is only slightly more
concentrated than common household
bleach; it’s less toxic than many
automotive and household chemicals;
and the resultant liquid from hosing
down a spill is indistinguishable from
drinking water. An industry association
argued that many of these claims apply
to institutional and industrial sanitizers
and disinfectants in general.
vii. No need for additional
regulations. Several commenters stated
that there is no need for EPA to regulate
institutional and industrial disinfectants
because these products are already
adequately regulated by EPA waste
regulations, DOT’s packaging
requirements, and OSHA’s health and
safety standards. One commenter stated
that most manufacturers and
formulators of antimicrobial products
use containers that meet at least the
DOT Packing Group III standards for all
materials, because it’s not feasible to use
certain containers for DOT hazardous
materials and other containers for
products that aren’t DOT hazardous
materials.
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4. EPA response. EPA has decided to
change its approach for determining
which antimicrobial products that are
eligible for exemption must be subject to
the container regulations to prevent an
unreasonable adverse effect. The final
rule will implement Option 1 rather
than Option 3.
EPA believes that Option 1 is
acceptable because it is a legitimate,
reasonable interpretation of the
statutory language. In addition, making
determinations for subjecting products
to the container regulations based on
specific information, data or other
evidence of a problem to prevent
unreasonable adverse effects on the
environment is more straightforward
than making such a determination based
on arguments supporting the fact that
there could be unreasonable effects.
In changing the approach to Option 1,
EPA was partly convinced by the
comments and observations relating to
the standard of unreasonable adverse
effect. The process of registration
(including the submission and review of
data plus establishing label restrictions)
is intended to ensure that the pesticide
will not cause UAEs on the
environment. In other words, all
registered products have been
determined to meet a standard of not
causing UAEs on the environment. This
determination can be re-visited and
changed by EPA if UAEs are identified
during the process of reregistration or
other review, under the ongoing
mechanisms of FIFRA section 6(a)(2) (as
implemented by 40 CFR part 159) or
when other relevant information is
received by EPA.
If all eligible Toxicity Category I
antimicrobial products needed to be
subject to the container regulations to
prevent UAEs on the environment
(according to options 2 and 3 in the
supplemental notice), then currently we
should be seeing UAEs from the
containers of these products. This is
especially true given the relatively large
quantities of antimicrobial pesticides
used annually. As described in the
supplemental notice, in 1995
approximately 3,290 million pounds of
antimicrobial active ingredients were
used in the United States, compared to
1,222 million pounds of nonantimicrobial active ingredients.
However, EPA is unaware of a
substantial number of UAEs resulting
from the containers of antimicrobial
pesticides. Data from the California
Pesticide Illness Surveillance Program
indicate only a limited number of cases
where exposure to antimicrobial
pesticides was very likely to be
prevented if the container regulations
had been in place. (Ref.22) Given the
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limited number of incidents, we do not
believe it is appropriate to require all
eligible Toxicity Category 1
antimicrobial products to be subject to
the container regulations, and we
believe that a case-by-case approach is
better suited to the issue.
Because Congress didn’t provide
additional insight into what constitutes
an unreasonable adverse effect in the
context of section 19, EPA agrees with
the comment that it should have the
same meaning as in the FIFRA
registration standard in section 3(c)(5)
and the obligation for registrants to
report information about UAEs on the
environment in FIFRA section 6(a)(2).
While some of the public comments
were persuasive, EPA does not agree
with all of the comments submitted in
support of Option 1. For example, EPA
stands by the statements in the
supplemental notice that the statutory
language ‘‘unless the Administrator
determines that [an eligible
antimicrobial] product must be subject
to [the container] provisions to prevent
an unreasonable adverse effect on the
environment’’ provides considerable
flexibility for EPA to implement it by
establishing general criteria or by
product-specific decisions. In addition,
the lack of significant documented
legislative or statutory history on the
FQPA amendment to FIFRA section
19(h) makes it impossible to identify
Congress’s intent one way or another on
this issue. Moreover, the fact that this
language was added toward the end of
the legislation’s adoption indicates that
commenters’ statements regarding the
intent of section 19(h) may not be an
altogether accurate depiction of how
Congress intended this portion of
section 19(h) to be interpreted. EPA
believes that some antimicrobial
products may need to be subject to the
container regulations to protect human
health and the environment. These
products will be identified and
regulated by the process described in
Unit III.F. below. Finally, EPA believes
that the other regulations cited by
commenters including EPA waste
regulations, DOT’s packaging
requirements, and the OSHA health and
safety standards overlap to some degree
with the pesticide container regulations
but generally address different stages of
a container’s life cycle. Also, these
regulations apply to other pesticides
and therefore do not uniquely affect
antimicrobials.
F. Process for EPA to Make These
Determinations (§§ 165.23(d),165.43(e)
and 165.63(e))
1. Final regulations. The final
regulations describe the process and
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standards by which EPA may determine
that an antimicrobial pesticide product
that would otherwise be exempt must be
subject to the container regulations to
prevent an unreasonable adverse effect
on the environment. EPA may make this
determination if all of the following
conditions exist:
• EPA obtains information, data or
other evidence of a problem with the
containers of a certain pesticide product
or related group of products.
• The information, data or other
evidence is reliable and factual.
• The problem causes or could
reasonably be expected to cause an
unreasonable adverse effect on the
environment.
• Complying with the container
regulations could reasonably be
expected to eliminate the problem.
The process in the final rule for
making these determinations is based on
the regulations in 40 CFR 152.164 for
classifying products as restricted use
pesticides. If EPA determines that an
antimicrobial pesticide product that
would otherwise be exempt must be
subject to the container regulations to
prevent an unreasonable adverse effect
on the environment, EPA may:
• Require, by rule, that the product be
repackaged (if applicable) and
distributed or sold in containers that
comply with all or some of the
requirements in these regulations; or
• Notify the applicant or registrant of
EPA’s intent to make such a
determination. After allowing the
applicant or registrant a reasonable
amount of time to reply, EPA may
require, by notification and as a
condition of registration, that the
product be repackaged (if applicable)
and distributed or sold in containers
that comply with all or some of the
requirements in these regulations.
For the purposes of notification, 60 days
would be a reasonable amount of time
to reply, although EPA may, in its
discretion, provide more time. This
process allows EPA to apply all of the
requirements in the nonrefillable
container, refillable container and
repackaging subparts to the product.
Alternatively, EPA could apply a subset
of the container-related requirements to
the product if compliance with some
but not necessarily all of the
requirements would eliminate the
problem.
EPA may deny registration or initiate
cancellation proceedings if the
registrant fails to comply with the
container and, if appropriate, the
repackaging regulations within the time
frames established by EPA in the rule or
in its notification.
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2. Changes. Because we are finalizing
Option 1 rather than Option 3 in the
supplemental notice, the final rule
provides more specific criteria and a
better-defined process for EPA to make
determinations to prevent an
unreasonable adverse effect on the
environment. The criteria and process
are outgrowths of comments on the
supplemental notice and the following
potential regulatory provision from the
supplemental notice:
EPA may determine that an antimicrobial
product or products must comply with the
container standards. EPA may consider
evidence such as field studies, use history,
accident data, monitoring data, or other
pertinent evidence in deciding whether the
product must comply with the container
standards to prevent an unreasonable adverse
effect on the environment.
3. Comments. Many commenters
provided suggestions and information
about how they believe the case-by-case
determinations should be made. While
the actual language varied among
commenters, the respondents agreed
that EPA needs specific evidence of a
problem related to containers before
EPA can determine a product must be
subject to the container regulations to
prevent an unreasonable adverse effect.
4. EPA response. EPA believes that
the criteria and process in the final
regulations for making determinations
to prevent an UAE represent a
legitimate, reasonable, straightforward
interpretation of the statutory language.
In addition, we think these criteria and
the process for making determinations
are similar to EPA’s current systems.
EPA has the ability to re-visit a
product’s registration standard of not
causing UAEs and change it if UAEs are
identified during the process of
reregistration or other review, under the
ongoing mechanisms of FIFRA section
6(a)(2) (as implemented by 40 CFR part
159, PR Notice 98–3 (Ref. 55), PR Notice
98–4 (Ref. 54) and other guidance
documents) or when other relevant
information is received by EPA. The
criteria and process included in the
final rule are consistent with most
comments received on the supplemental
notice.
It is difficult to precisely identify the
kind of information that EPA would
consider sufficient and to characterize
in great detail the problems that could
trigger this regulatory provision,
because we cannot anticipate every
situation that might arise in the future.
However, the following items are
intended to provide some guidance on
the different factors that EPA will
consider in making determinations
about whether an antimicrobial product
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or products must be subject to the
container regulations:
• What kind of information, data or
other evidence of a problem with
containers has EPA obtained? This
could be descriptions of cases, incidents
or examples of problems or it could be
some other kind of information.
• How severe are the problems
identified in the information, data or
other evidence obtained by EPA? The
6(a)(2) regulations in 40 CFR part 159
define severity categories assigned to
incidents and PR Notice 98–3 (Ref. 55)
expands the definitions for incidents
involving humans and domestic
animals.
• How prevalent are the problems
identified in the information, data or
other evidence obtained by EPA? Are
the problems isolated or are they
widespread? EPA will evaluate the
prevalence of the problems and the
severity of the problems before taking
any action to subject the product or
products to the container regulations.
• Where do the problems occur in the
distribution chain? In other words,
whether the incidents occur
predominantly at the facilities of
manufacturers, retailers or end users
may affect our decision. Also, this
information may allow EPA to trace a
problem back to a certain facility or a
limited number of facilities.
• What is the company’s history in
terms of reacting to problems of
concern?
• Do the problems cause an
unreasonable adverse effect on the
environment?
• Could the problems reasonably be
expected to cause an unreasonable
adverse effect on the environment if
they continue to occur? For example,
about a decade ago, EPA received a
significant number of reports of a
household pesticide that exploded over
time. While these initial incidents may
not have directly led to a severe human
injury or illness, it is reasonable to
expect that someone could have been
injured or become ill if they were in a
garage or storage area when a container
exploded.
• Would complying with the
container regulations reasonably be
expected to eliminate the problem? If
the container regulations don’t address
the problem or would not mitigate the
problem, then EPA could consider other
approaches (such as establishing
conditions specific to that registration)
to mitigate the problem. As an example,
it is possible that a problem could be
caused by a problem with a specific
kind of container material. In this case,
the solution may be to require the
product to be distributed in a certain
container material or a container
material that has been treated, e.g.,
fluorinated high density polyethylene. It
is possible that some of these alternative
approaches may have other impacts
with respect to the container
regulations. For example, requiring a
product to be distributed in a
nonrefillable container that is rigid
rather than non-rigid would increase the
number of nonrefillable container
standards the product must comply
with.
G. Summary Table of the Scope for
Antimicrobial Products
The following tables compare the
approach for regulating antimicrobial
products in the final regulations and the
supplemental notice. Table 4 compares
the exemption criteria in the final rule
with the criteria discussed in the
supplemental notice. Table 5 compares
whether certain kinds of products
(assuming they would otherwise be
exempt) are exempt from or subject to
the container standards in the final
regulations and the supplemental notice
approach.
TABLE 4.—EXEMPTION CRITERIA FOR ANTIMICROBIAL PRODUCTS IN THE FINAL RULE COMPARED TO THE SUPPLEMENTAL
NOTICE
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Criterion for Exemption
Approach in the Final Rule
Approach in the Supplemental Notice
FIFRA section 2(mm) antimicrobial
pesticide
As defined in FIFRA section 2(mm)
As defined in FIFRA section 2(mm)
Antimicrobial products that are not
FIFRA 2(mm) antimicrobial pesticides because they are subject
to a tolerance or food additive
regulation
Criterion is included as an additional criterion allowing exemption
Criterion wasn’t included; these would have been
subject to the container regulations
Antimicrobial product use categories that are considered
household, industrial, or institutional
10 antimicrobial product use categories are household, institutional or industrial. The additional
antimicrobial product use categories are:
• aquatic areas; and
• agricultural premises and equipment
9 antimicrobial product use categories were identified as household, institutional or industrial. The
additional antimicrobial product use categories
were:
• aquatic areas;
• agricultural premises and equipment; and
• human drinking water systems
Is not a hazardous waste when it
is intended to be disposed
Is not a hazardous waste as set out in 40 CFR part
261 when intended to be disposed
Does not meet the criteria for hazardous waste in
40 CFR part 261 when intended to be disposed
EPA has not specifically determined product must be subject
to container regulations to prevent an unreasonable adverse
effect
Criteria and a process for making the determination
are included in the final rule
Making case-by-case determinations was discussed as an option, but was not specifically included in the potential regulatory language
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47343
TABLE 5.—ANALYSIS OF WHETHER CERTAIN TYPES OF ANTIMICROBIAL PRODUCTS1 WOULD BE SUBJECT TO OR EXEMPT
FROM THE CONTAINER REGULATIONS - COMPARING THE FINAL RULE TO THE SUPPLEMENTAL NOTICE2
Antimicrobial Product Description
Final Rule
Supplemental Notice(Option 3)
Products that are subject to a tolerance or food additive regulation
Exempt from the regulations3
Subject to the regulations according to 2(mm) definition
Products that are exempt from, or
otherwise not subject to a tolerance or food additive regulation
Exempt from the regulations according to 2(mm)
definition3
Exempt from the regulations according to 2(mm)
definition3
Wood preservative or antifouling
paint intended to control only
micro-organisms
Exempt from the regulations according to 2(mm)
definition3
Exempt from the regulations according to 2(mm)
definition3
Wood preservative or antifouling
paint intended to control macroorganisms as well as micro-organisms
Subject to the regulations according to 2(mm) definition
Subject to the regulations according to 2(mm) definition
Agricultural fungicide or aquatic
herbicide
Subject to the regulations according to 2(mm) definition
Subject to the regulations according to 2(mm) definition
Product in Toxicity Category I
Exempt from the regulations3
Subject to all nonrefillable container requirements
except the residue removal standard; subject to
all refillable container requirements unless used
in swimming pools according to determination to
prevent UAE
Product in Toxicity Category II, III
or IV
Exempt from the regulations3
Exempt from the regulations3
Product used only in swimming
pools and closely related sites
Exempt from some refillable container and repackaging requirements if subject to the regulations
for any reason
Exempt from some refillable container and repackaging requirements if it met all of the exemption
criteria and is in Toxicity Category I
1 In
this table, the term antimicrobial has a broad interpretation, i.e., as described in FIFRA section 2(mm)(1)(A).
antimicrobial products must comply with the new labeling requirements. (See Unit IX. for more details about the label regulations.) This
table refers only to complying with the container-related regulations, i.e., standards for nonrefillable containers, refillable containers and repackaging.
3 The product is exempt from the regulations unless it would be subject because of other triggers, such as it is a hazardous waste when intended to be disposed.
2 All
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H. Other Pesticide Products Subject to
These Regulations (§§ 165.23 (e),
165.43(f) and 165.63(f))
1. Overview—i. Final regulations. For
nonrefillable containers, all pesticide
products other than MUPs, plantincorporated protectants and exempt
antimicrobial products are subject to the
nonrefillable container standards.
However, only the ‘‘higher risk’’
products are subject to all of the
nonrefillable container requirements.
The ‘‘lower-risk’’ products are subject
only to the basic DOT requirements. In
particular:
• A product must comply with all of
the nonrefillable container requirements
if it is classified in at least one of the
following categories: (1) Toxicity
Category I; (2) Toxicity Category II; or
(3) Restricted use product.
• All other products (those in
Toxicity Category III or IV that are not
restricted use products) must comply
only with the basic DOT requirements
in 49 CFR 173.24. If the pesticide
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product meets the definition of a
hazardous material in 49 CFR 171.8, the
DOT requires it to be packaged
according to 49 CFR parts 171–180.
The final rule does not distinguish
between higher risk and lower risk
products for the refillable container and
repackaging regulations. In other words,
pesticide products other than MUPs,
plant-incorporated protectants and
exempt antimicrobial products must
comply with all of the refillable
container and repackaging standards.
The only exception is that antimicrobial
products that are used in swimming
pools and closely related sites are
subject to a reduced number of the
requirements, as described in Unit III.D.
ii. Changes. The 1994 NPRM
proposed that the container regulations
would generally apply to all end use
pesticide products and all containers,
regardless of the pesticide market sector.
The proposed container regulations
included requirements that are
equivalent to some DOT requirements,
such as marking, container integrity,
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reclosing securely and a drop test, and
some requirements that are pesticidespecific, such as standard closures, oneway valves, and the residue removal
standard. Many commenters opposed
the broad scope of the regulations and
requested EPA to exempt one or more
subsets of pesticides from the container
requirements.
In the 1999 supplemental notice, EPA
described a potential regulatory option
for products other than antimicrobials
that would exempt some pesticides and
containers from the final rule. Rather
than exempt products based on the
pesticide market sector or the type of
pesticide (as specified by the
commenters on the proposal), EPA’s
approach was to exempt pesticides
based on the relative risk they posed.
The regulatory approach in the
supplemental notice would have
exempted manufacturing use products,
as we proposed in 1994, and included
a previously described set of standards
for antimicrobial products that would be
eligible for exemption. For all other
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products, a product would be subject to
the regulations if it met any one of the
following criteria:
• The product is classified in Toxicity
Category I or II;
• The capacity of the container is
equal to or larger than 5 liters (1.3 gal)
for liquids or 5 kilograms (11.0 lbs) for
solids;
• The product’s labeling permits
outdoor use and includes at least one of
the specified environmental hazard
statements.
The container size and environmental
hazard label statement criteria would
have captured many products in
Toxicity Category III and IV so they
would have been subject to the
regulations.
About 18 respondents provided
comments on these general (nonantimicrobial) scope criteria in the
supplemental notice, consisting largely
of individual registrants and registrant
groups. The commenters generally
agreed that it was appropriate to
differentiate the stringency of the
regulations based on the relative risk
posed by the products and containers.
None of the commenters wholly
supported the approach in the
supplemental notice and there was no
general agreement in an approach
among the suggestions provided by the
respondents. Some commenters stated
that certain standards (either the DOT
Packing Group III standards or the
standards in a DOT limited quantity
exception) should apply to all products.
Many commenters suggested changes to
the Toxicity Category and container size
criteria. None of the commenters
supported the environmental hazard
statement criteria. A few commenters
suggested other exemptions that should
be included, such as exempting all
residential use products.
After carefully reviewing these
comments and conducting an analysis
of the products that would be regulated
using the supplemental notice criteria,
EPA decided to revise the approach in
the final rule for regulating pesticide
products other than MUPs, plantincorporated protectants and
antimicrobials that are exempt. As
described above, the approach for the
nonrefillable container standards, which
differentiates between ‘‘higher risk’’ and
‘‘lower risk’’ products, is different from
the approach for the refillable container
and repackaging requirements, which
do not make that distinction.
iii.Refillable container and
repackaging regulations. Pesticide
products other than MUPs, plantincorporated protectants and exempt
antimicrobial products must comply
with all of the refillable container and
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repackaging standards. One exception is
that antimicrobial products that are
used in swimming pools and closely
related sites are subject to a reduced
number of the requirements.
2. Alternative approach and rationale
for changes. The final rule approach for
regulating pesticide products that are
not otherwise exempt was developed
based on the comments on the
supplemental notice and on an analysis
conducted by EPA. The broad
comments related to substantial changes
in the approach are described in this
subunit, while comments on the specific
criteria in the supplemental notice are
discussed individually in subunits
below.
i. Comments - overall approach. EPA
posed six questions in the supplemental
notice related to the scope of products
subject to the container regulations. The
first question was ‘‘Is it appropriate to
apply the container standards only to
the higher-risk pesticides?’’ Eight
respondents specifically addressed this
question and seven of them generally
agreed with EPA that it is reasonable to
apply different levels of regulation to
higher-risk and lower-risk pesticides.
However, the commenters differed in
their recommendations for regulating
the lower-risk pesticides. Only one of
the eight commenters, a non-agricultural
registrant group, specifically supported
a complete exemption for the lower-risk
pesticides. Some commenters took a
middle ground. In particular, the
comments from a registrant group and
three registrants were a bit vague,
stating that it is appropriate to apply the
container standards only to the higher
risk pesticides and that lower-risk
pesticides should not be subject to the
same requirements. Several commenters
opposed the approach of completely
exempting some products. Two
registrant groups explicitly supported
an option where lower risk pesticides
would be subject to some regulations,
although different standards would be
appropriate. Also, the commenter who
didn’t support distinguishing between
risk levels was a registrant who stated
that the requirements for DOT Class 9
materials should apply to all pesticides
that are not DOT hazardous materials.
The second question was ‘‘Are the
criteria being considered by EPA to
distinguish between higher-risk and
lower-risk pesticides appropriate?’’ The
same eight commenters addressed this
question and none of them believed that
the criteria in the supplemental notice
were appropriate for distinguishing
between higher-risk and lower-risk
pesticides. An agricultural registrant
group commented that toxicity and
container size are generally appropriate
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criteria, but questioned the viability of
using these criteria because of the wide
range of combinations of toxicity
(human health and environmental),
container sizes and distribution and
handling practices. This commenter
supports establishing the DOT Packing
Group III standards as a minimum for
agricultural pesticides in nonrefillable
containers. A registrant group and a
registrant stated that DOT limited
quantity provisions should be
authorized for pesticides that are not
DOT hazardous materials. The
regulatory language recommended by
one of these commenters would require
pesticide products to comply with all
nonrefillable container standards unless
they were specifically exempt or subject
to a limited quantity exception. Four
commenters--a registrant group and
three registrants--strongly opposed the
environmental hazard statement
criterion because they don’t believe the
environmental hazard statements on the
label are appropriate indicators of risk.
One of them said that toxicity category
alone should be used to distinguish
between higher-risk and lower-risk
pesticides. A non-agricultural registrant
group questioned the appropriateness of
human toxicity characteristics for
packaging regulations that, it claims,
deal primarily with storage and
disposal. This commenter urged EPA to
develop alternate criteria, such as the
potential for the product to leak from
containers and/or to persist in the
environment.
In addition, a registrant group and a
registrant who addressed the above
question provided more detailed
comments on an alternate approach.
These commenters stated that all
agricultural pesticides distributed in
nonrefillable containers should comply
with the DOT packaging standards.
Under this option, pesticides that are
not DOT hazardous materials would
comply with the Packing Group III
standards or, if appropriate, one of the
limited quantity exceptions. The
registrant group stated that having
minimum requirements on pesticide
integrity is in the best interest of
agriculture, the public and our industry.
Another registrant provided a detailed
description of an alternate approach.
This commenter split the regulations
into two primary issues - (1) container
design and integrity testing and (2)
container residue removal standards
and others - based on the goals of the
rule and their financial impact. This
agricultural registrant strongly believes
that all pesticides in nonrefillable
containers should be required to use
DOT Packing Group III containers as a
minimum safety standard. On the other
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hand, this respondent believes that it
may be reasonable and appropriate to
consider exempting lower-risk
pesticides from some standards, such as
the residue removal requirement.
ii. EPA response - overall approach.
These comments prompted EPA to
reconsider the approach discussed in
the supplemental notice where lowerrisk pesticides would be completely
exempt from the nonrefillable container
standards. EPA agrees with the point
made by some commenters that all
containers should meet standards for
integrity and compatibility and is
modifying the final rule accordingly.
However, EPA believes that the
minimum standards for integrity are
different between nonrefillable and
refillable containers.
In general, DOT has two different sets
of package integrity standards. The most
thorough set of requirements are the
performance-oriented packaging
standards, which include drop,
leakproofness, hydrostatic pressure,
stacking and vibration tests. These tests
may vary in stringency depending on
the packing group of the material. For
example, a Packing Group I test involves
a drop from 1.8 meters (5.9 feet) while
a Packing Group III test has a drop from
0.8 meters (2.6 feet). The other set of
requirements are the packaging
standards in 49 CFR part 173 subpart B,
which are referenced in DOT limited
quantity exceptions. In other words,
packages that are subject to a limited
quantity exception must comply with
the standards in subpart B of part 173,
even though they are exempt from the
full array of performance-oriented
packaging tests and other standards.
The requirements in 49 CFR part 173
subpart B include many different
standards related to ‘‘Preparation of
Hazardous Materials for
Transportation.’’ Some of these
requirements address aspects of
transportation other than packaging,
such as the loading and unloading of
transport vehicles, or establish
requirements for specific modes of
transportation, such as general
requirements for transportation by
aircraft. Therefore, it would not be
appropriate for EPA to reference all of
part 173 subpart B, because we are only
interested in incorporating the DOT
standards that address packaging
design, construction and marking. After
analyzing the subpart B regulations,
EPA believes that the general
requirements for packagings and
packages in 49 CFR 173.24 are
appropriate basic standards that all
nonrefillable containers must meet. The
standards in 49 CFR 173.24 address
container integrity, compatibility,
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closures and outage/filling limits. These
DOT standards cover the same areas as
the proposed requirements for
nonrefillable container integrity/
compatibility in § 165.102(b) and
reclosing containers securely in
§ 165.102(d)(3). EPA believes that all
nonrefillable containers should easily be
able to comply with these requirements,
yet they provide a standard that we
could enforce in situations where
container problems may arise.
Therefore, the final rule references the
general requirements for packagings and
packages in 49 CFR 173.24 as the basic
standards for all nonrefillable
containers, unless the pesticide product
is exempt from the regulations.
On the other hand, EPA believes that
the DOT Packing Group III standards,
including the performance-oriented
packaging tests, are an appropriate
minimum standard for refillable
containers. Refillable containers need to
be sturdier, stronger and able to
withstand more stress than
nonrefillables because they spend more
time in use (i.e., full of pesticide) and
in the lanes of transportation. Because
refillable containers are returned to the
refiller and/or registrant repeatedly over
the useful life of the containers, they are
subject to more wear and tear than
containers that are used once. Therefore,
EPA believes that it is appropriate to
require refillable containers to be
capable of meeting DOT’s packaging
standards at the Packing Group III level,
if the pesticide product is not a DOT
hazardous material. If the pesticide
product is a DOT hazardous material, it
must comply with the relevant DOT
standards.
3. Nonrefillable containers: human
toxicity criterion—i. Final regulations.
For pesticide products other than MUPs,
plant-incorporated protectants, and
exempt antimicrobial products, a
pesticide product must comply with all
the nonrefillable container requirements
if it is classified in Toxicity Category I
or II, as set out in 40 CFR 156.62.
ii. Changes. For pesticide products in
nonrefillable containers, this criterion is
identical to the one set forth in the
potential alternative regulatory text in
the 1999 supplemental notice. EPA
continues to believe that the most
hazardous groups of pesticides in terms
of human toxicity - those in Toxicity
Category I and Toxicity Category II should be subject to the nonrefillable
container standards. Most problems
with handling containers will lead to
human exposure, as a result of dripping,
glugging, leaking, or container failures,
so EPA believes that human toxicity is
an appropriate criterion. Furthermore,
EPA believes that products in Toxicity
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Category I and II pose a significant
enough risk in these situations that
these products should be subject to the
nonrefillable container requirements.
EPA is participating in a global effort
to harmonize the classification and
labeling of chemicals for human and
environmental hazards, which is being
led by international agencies such as the
Organization for Economic Co-operation
and Development (OECD), the
International Labor Organization and
the UN Committee of Experts on the
Transportation of Dangerous Goods. The
global harmonization effort resulted in
new definitions for toxicity
characteristics and a new Category V.
The categories and rationale were
described in OECD Series on Testing
and Assessment Number 33,
Harmonized Integrated Classification
System for Human Health and
Environmental Hazards of Chemical
Substances and Mixtures. That
document has since been superceded by
a consolidated document published by
the United Nations Economic
Commission for Europe (UNECE)
entitled Globally Harmonized System of
Classification and Labeling of
Chemicals (GHS) and is available at the
following Web site: http://
www.unece.org/trans/danger/publi/ghs/
ghslrev01/01filesle.html. (Ref. 16)
Each country will select elements of the
system deemed appropriate for
regulating transport, worker and
environmental protection. When EPA
modifies its definitions of toxicity
categories in 40 CFR part 156 to
harmonize with the OECD guidelines,
EPA plans to revise the toxicity category
criteria in § 165.23(e) to incorporate the
new toxicity categories. The criteria and
signal words associated with the GHS
toxicity categories are different than
EPA’s existing criteria and signal words.
Therefore, the universe of products
subject to the full set of nonrefillable
container standards and the universe of
products subject only to the basic DOT
packaging requirements will likely
change.
4. Nonrefillable containers: other
toxicity criterion—i. Final regulations.
For pesticide products other than MUPs,
plant-incorporated protectants, and
exempt antimicrobial products, a
pesticide product must comply with all
the nonrefillable container requirements
if it is classified by EPA as a restricted
use product.
ii. Changes. This criterion is different
than the criterion described in the
supplemental notice that would have
required a product to comply with the
nonrefillable container regulations if its
labeling allowed outdoor use and
included at least one of the specified
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environmental hazard statements.
Rather than relying on the
environmental hazard statements on
pesticide labels, such as ‘‘This pesticide
is toxic to birds,’’ EPA decided to
change this criterion to products that are
classified as restricted use products,
which was discussed as an option in the
supplemental notice. According to an
EPA analysis, fewer than 250 restricted
use products are in Toxicity Category III
or IV (i.e., that are not already captured
by the human toxicity criteria). (Ref. 45)
iii. Comments. Many commenters--all
registrant groups and registrants-commented on the environmental
toxicity criterion in the supplemental
notice. One non-agricultural registrant
group stated that some of the criteria
covered by the hazard statements, such
as whether a pesticide leaches through
the soil to groundwater, are appropriate
and should be substituted for the human
toxicity criteria. A registrant group and
a registrant opposed any environmental
criteria. A registrant group and two
registrants opposed the environmental
hazard criterion because they did not
agree that the actual use (indoor or
outdoor) of a pesticide is a realistic basis
for determining exemptions from the
container regulations. These
commenters said that a spill or release
could happen at any point during
transportation, storage or handling and
that all pesticide products share the
same lanes of transportation. Therefore,
these commenters believe the
distinction between whether the
pesticide is used indoors or outdoors is
irrelevant. Several commenters opposed
the environmental hazard criterion
because they don’t believe the
environmental hazard statements on the
label are appropriate indicators of risk.
Several commenters addressed the
option discussed in the supplemental
notice for including a criterion for
pesticides that are classified as
restricted use for environmental or
ecological reasons. In particular, a
registrant group and several registrants
commented that ‘‘while it is true that
compounds that are restricted in their
use for ecological reasons would have
some of the specified environmental
hazard statements ..., it is also true that
many compounds with little or no
potential for risk could easily contain
such language.’’ This statement implies
that these respondents distinguish
between the risks posed by pesticides
that are restricted in their use for
ecological reasons - which are higher and the risks posed by other pesticides.
iv. EPA response. As stated in the
supplemental notice, EPA continues to
believe that it is important and
necessary to account for environmental
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factors when evaluating the risks posed
by pesticide containers. After
considering the comments and reevaluating the environmental hazard
statement approach described in the
supplemental notice, EPA is changing
the approach in the final regulations.
EPA believes that the environmental
hazard statement option, as described in
the supplemental notice, would be
difficult to implement because each
label would have to be evaluated and
because the ‘‘catch-all’’ standard
included in the supplemental notice
(‘‘Any environmental hazard statement
pertaining to wildlife, fish, birds or
groundwater’’) raises some ambiguity
about which products would be
included by this criterion. Also, while
EPA doesn’t necessarily agree with all of
the comments, an EPA analysis (Ref. 78)
raised questions about whether using
the environmental hazard statements on
the label would capture the highest-risk
pesticides. Finally, the final rule uses
the criterion of restricted use
classification to distinguish between
levels of regulation (subject to all of the
nonrefillable container standards versus
subject to the basic DOT standards)
rather than to distinguish between
whether the product is regulated or
exempt. Therefore, we can afford to set
the criterion at a level that would focus
on the most environmentally risky
products, because the other products
will be subject to basic container
integrity and compatibility standards,
rather than being completely exempt.
The criteria that EPA utilizes to
restrict an end use product to use by
certified applicators (or persons under
their direct supervision) are described
in 40 CFR 152.170. The general criteria
for restricting the use of a product are
that EPA determines that:
• The product’s toxicity exceeds one
or more of the specific hazard criteria in
152.170, or evidence substantiates that
the product or use poses a serious
hazard that may be mitigated by
restricting its use;
• The product’s labeling is not
adequate to mitigate these hazards;
• Restriction of the product would
decrease the risk of adverse effects; and
• The decrease in risks of the
pesticide as a result of restriction would
exceed the decrease in benefits.
Section 152.170 lists specific human
and ecological toxicity endpoints that
cause a product to be considered for
restricted use classification. In addition,
the regulations state that EPA may
consider evidence such as field studies,
use history, accident data, monitoring
data or other pertinent evidence in
deciding whether the product or use
may pose a serious hazard that could be
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mitigated by restricted use
classification.
An analysis of products in EPA’s
REFS data base shows that many
restricted use products are also
classified in Toxicity Category I or II.
However, there are about 225 restricted
use products in Toxicity Category III or
IV and all of these products were
restricted at least partly for
environmental/ecological reasons. (Ref.
45) In particular, the criteria for
restricting the Toxicity Category III/IV
products include ground water
contamination; toxicity to fish, birds, or
aquatic organisms; and hazard to
wildlife or non-target organisms.
5. Nonrefillable containers: container
size criterion—i. Final regulations.
Container size is not a criterion in the
final regulations for determining
whether a pesticide product is subject to
the nonrefillable container regulations.
ii. Changes. The approach in the
supplemental notice included a
container size limit as one of the criteria
for being subject to the nonrefillable
container regulations. Specifically, a
product would have been subject to the
nonrefillable container regulations if the
container’s capacity was equal to or
larger than 5.0 liters (1.3 gallons) for
liquid formulations or 5.0 kilograms
(11.0 pounds) for solid formulations.
EPA decided not to incorporate the
container size criterion into the final
rule for nonrefillable containers because
of other changes in the structure of the
final regulations. In particular, the final
rule uses the scope criteria to
distinguish between levels of regulation
(subject to all of the nonrefillable
container standards versus subject to the
basic DOT standards) rather than to
distinguish between whether the
product is regulated or exempt. The
criteria in the final rule subject the most
toxic and most risky pesticides — those
in Toxicity Categories I and II and any
others that are restricted use products —
to the full set of nonrefillable container
requirements. All other products that
are not specifically exempt are subject
to basic container integrity and
compatibility standards, rather than
being completely exempt. EPA believes
the basic DOT packaging standards offer
an acceptable level of protection for the
products that are in Toxicity Categories
III and IV and that are not restricted use
products. Therefore, a container size
criterion is not necessary for
nonrefillable containers.
6. Refillable containers and
repackaging—i. Final regulations.
Pesticide products other than MUPs,
plant-incorporated protectants and
exempt antimicrobial products must
comply with all of the refillable
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container and repackaging standards.
One exception is that antimicrobial
products that are used in swimming
pools and closely related sites are
subject to a reduced number of the
requirements.
ii. Changes. The regulatory language
is different than the approach described
in the supplemental notice, which
described the criteria of Toxicity
Category I or II, container size and
environmental hazard statements for
subjecting a pesticide product to the
refillable container and repackaging
regulations. However, the net effect of
the scope language in the supplemental
notice is very similar to the scope of the
final rule. Because nearly all, if not all,
refillable containers are larger than the
container size identified in the
supplemental notice of 5 liters (1.3
gallons) or 5 kilograms (11 pounds), the
supplemental notice criteria would have
subjected nearly all, if not all, products
in refillable containers to the
regulations.
iii. Comments. Respondents did not
specifically address how the general
scope criteria should apply to refillable
containers. A few commenters
specifically limited some points to
nonrefillable containers, although most
did not. Therefore, EPA believes that the
comments described in Units III.H.1.
though III.H.5. generally also apply to
refillable containers.
iv. EPA response. Under the
supplemental notice approach, nearly
all refillable containers would have
been subject to the refillable container
and repackaging regulations because of
the container size criterion of 5 liters for
liquids and 5 kilograms for solids.
Although the container size criterion is
not being incorporated into the final
regulations, EPA believes it is necessary
for products that are not specifically
exempt to comply with the refillable
container and repackaging regulations.
First, one of the goals of the refillable
container and repackaging regulations is
to minimize cross-contamination in
refillable containers. The regulatory
standards in the final rule - including
one-way valves, tamper-evident devices,
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having registrants develop cleaning
procedures, and requiring refillers to
clean containers if necessary - are
necessary for preventing crosscontamination in all products. All
products that are distributed or sold
must have the composition as stated in
their confidential statements of formula
and not be adulterated. This standard
does not differ based on the toxicity of
the product, the container size or any
other factor. Therefore, minimizing the
chance of cross-contamination is one
reason that the final regulations were
changed so that the refillable container
and repackaging regulations apply to all
products that are not specifically
exempt. Note that certain antimicrobial
products are subject to a reduced
number of requirements, as described in
Unit III.D.
Second, the repackaging regulations
assign responsibility for certain
requirements to registrants and to
refillers, in addition to setting out the
procedures that both parties must follow
for pesticide products to be repackaged
into refillable containers. EPA believes
that it is important for all products that
are not specifically exempt to be
handled consistently under the
repackaging regulations. We think that
this consistency will facilitate
compliance by both the registrants and
refillers.
Third, as stated earlier, the final rule
takes the approach that all containers
should meet standards for integrity and
compatibility. EPA believes that the
DOT Packing Group III standards,
including the performance-oriented
packaging tests, are an appropriate
minimum standard for refillable
containers. Refillable containers need to
be sturdier, stronger and able to
withstand more stress than
nonrefillables because they spend more
time in use (i.e., full of pesticide) and
in the lanes of transportation. Because
refillable containers are returned to the
refiller and/or registrant repeatedly over
the useful life of the containers, they are
subject to more wear and tear than
containers that are used once. Therefore,
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EPA believes that it is appropriate to
require refillable containers to be
capable of meeting DOT’s packaging
standards at the Packing Group III level,
if the pesticide product is not a DOT
hazardous material. If the pesticide
product is a DOT hazardous material, it
must comply with the relevant DOT
standards.
7. Changes to the container vs. label
regulations—i. Final regulations. In
general, all products must comply with
the container labeling requirements —
the labeling regulations do not exempt
MUPs or certain antimicrobial products.
One exception is that plant-incorporated
protectant container-related labeling
instructions will be determined by EPA
on a case-by-case basis until specific
labeling guidance for plant-incorporated
protectants are promulgated under 40
CFR part 174. This approach is
discussed in more detail in Unit IX.
ii. Changes. This is the same approach
described in the 1999 supplemental
notice except for the case-by-case
handling of plant-incorporated
protectants.
I. Flow Chart/Summary
The full scope of the final pesticide
container and containment rule is
summarized in this section. Different
sections of the final rule apply to
different subsets of products:
• The label requirements apply to all
products.
• The containment structure
requirements apply to agricultural
products (stored in stationary pesticide
containers by retailers, custom
applicators and custom blenders).
• The nonrefillable container,
refillable container and repackaging
requirements apply to products other
than MUPs, plant-incorporated
protectants and certain antimicrobial
products, as shown in Figure 1.
Within Figure 1, there is a box with
the question ‘‘Is it an antimicrobial
product that meets all four criteria?’’
This box represents a placeholder for
the flow chart in Figure 2.
BILLING CODE 6560–50–S
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IV. Container Regulations—
Relationship with the Department of
Transportation Regulations
A. Background
1. Department of Transportation
Hazardous Materials Regulations. The
U.S. Department of Transportation
(DOT) Hazardous Materials Regulations
(HMR) are based on the authority in the
Federal hazardous materials
transportation law, the Hazardous
Materials Transportation Act, and are
found in 49 CFR parts 171 through 180.
The HMR establish standards governing
a wide range of the safety aspects of
transportation, including requirements
for the classification of materials,
packaging (including manufacture,
continuing qualification and
maintenance), hazard communication
(i.e., package marking, labeling,
placarding, and shipping
documentation), transportation,
handling and incident reporting.
Some, but not all, pesticide products
are defined as DOT hazardous materials
by 49 CFR 171.8. A pesticide product
may be classified as a DOT hazardous
material for displaying any of the
hazards identified in the DOT
regulations, which are defined in nine
different classes. Some DOT hazard
classes include several different
divisions. The most common hazard
classes and divisions for pesticide
products include:
• Class 3: flammable or combustible
liquids;
• Division 6.1: poisonous materials;
• Class 8: corrosive materials; and
• Class 9: miscellaneous hazardous
materials, such as marine pollutants.
Pesticide products that are DOT
hazardous materials are required under
existing DOT regulations to comply
with all applicable regulations in all of
the safety areas mentioned above classification, packaging, hazard
communication, transportation and
handling. For pesticide products that
are not DOT hazardous materials, EPA
has focused on the DOT requirements
for package design (and manufacture,
continuing qualification, and
maintenance) and package marking,
because these are the areas that overlap
with the proposed pesticide container
regulations. In other words, EPA is not
adopting the HMR standards for DOT
labeling, placarding, shipping
documentation, transportation and
handling, and incident reporting
because these areas are generally
outside the scope of the pesticide
container regulations.
The DOT HMR include general
packaging requirements that address
areas such as compatibility, closures,
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venting, and filling limits. The HMR
also set out performance standards and
related tests that packaging must meet,
including drop, leakproofness,
hydrostatic pressure, stacking, and
vibration tests. The stringency of these
tests varies according to the packing
group (PG) of the material being
transported. The packing group
represents a measure of the relative
hazards, where PG I includes materials
that pose a relatively great hazard and
PG III includes materials that pose a
relatively minor hazard. Within a given
hazard class or division, the DOT HMR
assign packing groups based on the
materials characteristics, or the
regulations refer to the hazardous
materials table in 49 CFR 172.101 for
substance-specific assignments of
packing groups. Most pesticide products
that are classified as DOT hazardous
materials are in Packing Group III,
although some are in PG II and a few are
in PG I.
The HMR include exceptions from
some portions of the overall regulatory
scheme in certain situations, e.g., for
damaged packages placed in salvage
drums (49 CFR 173.3), for small
quantities of hazardous materials (49
CFR 173.4) and for the shipment of
waste materials (49 CFR 173.12). Also,
the regulations in 49 CFR 173.150
through 173.156 set out limited quantity
and consumer commodity exceptions
for different hazard classes. The limited
quantity exceptions provide relief from
some of the HMR requirements,
specifically the labeling requirements
(unless the package is transported by
aircraft), the placarding provisions, and
the testing standards in 49 CFR part 178.
Also, if a limited quantity meets the
definition of consumer commodity,
relief from the shipping paper
requirements is provided in many cases.
Pesticide products that are classified
as DOT hazardous materials must
continue to be packaged in accordance
with the DOT HMR. Nothing in the
pesticide container regulations changes
the specific requirements in the HMR
that apply to pesticide products based
on the criteria in the DOT regulations.
Additionally, the pesticide container
regulations do not change the stringency
of the DOT HMR. If a pesticide product
is categorized as a PG II material, it
would continue to have to meet the PG
II standards and likewise for products in
PG I or PG III.
2. Final regulations (§§ 165.25(a), (b)
and (c), and 165.45(a), (b) and (c)). The
final regulations adopt and refer to some
of the HMR for pesticides that are
subject to this final rule. The approach
in the final rule is closely tied to the
changes in scope described in Unit III.
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Some products, including MUPs, plantincorporated protectants, and some
antimicrobial products are completely
exempt from the container regulations
and are not included in the following
discussion because they are exempt. All
other products are subject to the final
regulations.
For pesticide products that are lower
risk (in Toxicity Category III or IV and
not restricted use products) in
nonrefillable containers, the
nonrefillable containers must comply
only with the general requirements for
packagings and packages in 49 CFR
173.24. No other requirements in EPA’s
pesticide container regulations apply to
these lower risk products. Of course, if
any of these products are DOT
hazardous materials, they must comply
with all applicable DOT regulations. For
the purpose of enforcing the pesticide
container regulations, however, EPA is
only referring to and adopting 49 CFR
173.24 for any lower risk products that
are subject to the regulations, regardless
of whether or not they are classified as
DOT hazardous materials.
Pesticide products that are higher risk
(in Toxicity Category I or II or a
restricted use product) in nonrefillable
containers and all products in refillable
containers must be packaged in a
container that is designed, constructed,
and marked to comply with the
requirements of 49 CFR 173.24, 173.24a,
173.24b, 173.28, 173.155, 173.203,
173.213, 173.240(c), 173.240(d),
173.241(c), 173.241(d), part 178 and part
180 that apply to a Packing Group III
material. These portions of the DOT
regulations, which are described in
more detail in later sections of this
preamble unit, include:
• General requirements for
packagings and packages (§§ 173.24,
173.24a, 173.24b);
• Reuse, reconditioning and
remanufacture of packagings (§ 173.28),
except for the leakproofness test
specified in § 173.28(b)(2);
• Exceptions for Class 9 materials,
miscellaneous hazardous materials
(§ 173.155);
• Non-bulk packagings for hazardous
materials in Packing Group III
(§ 173.203 for liquids and § 173.213 for
solids);
• Portable tanks, closed bulk bins and
intermediate bulk containers for certain
low hazard materials (§§ 173.240(c) and
173.240(d) for low hazard solid
materials and §§ 173.241(c) and
173.241(d) for low hazard liquid and
solid materials);
• Specifications for Packagings (part
178), including non-bulk performanceoriented packaging standards (subpart
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L), testing of non-bulk packagings and
packages (subpart M), intermediate bulk
container (IBC) performance-oriented
standards (subpart N), and testing of
IBCs (subpart O); and
• Continuing qualification and
maintenance of packagings (part 180)
Again, products that are DOT
hazardous materials must comply with
all applicable DOT regulations. For the
purposes of enforcing the pesticide
container regulations, the final rule
states that a pesticide product that
meets the definition of a hazardous
material in 49 CFR 171.8 must be
packaged in a container that is
‘‘designed, constructed and marked’’ to
comply with the requirements of 49 CFR
parts 171–180. Including the phrase
‘‘designed, constructed and marked’’
allows EPA to focus on the DOT
requirements for package design (and
manufacture, continuing qualification,
and maintenance) and package marking,
as described above, rather than the HMR
standards for DOT labeling, placarding,
shipping documentation, transportation
and handling, and incident reporting.
Because the pesticide container
regulations refer to and adopt certain
DOT requirements, these requirements
also are EPA standards that can be
enforced by EPA and the State agencies
that implement EPA’s pesticide
programs. However, EPA and the State
pesticide programs will enforce only the
49 CFR requirements that are referred to
and adopted in the pesticide container
regulations; not the full DOT HMR.
Clearly, DOT maintains authority to
enforce all of its regulations against
parties that are subject to the HMR.
The final rule includes two other
provisions related to the DOT standards.
These provisions are discussed in more
detail in Units IV.E. and IV.F. First, if
DOT proposes to change any of the
regulations that are incorporated into
the pesticide container regulations, EPA
will provide notice of the proposed
changes and an opportunity to comment
in the Federal Register. Following
notice and comment, EPA will take final
action regarding whether or not to revise
its rules and the extent to which any
such revision will correspond with
revised DOT regulation. Second, the
regulations include a provision for
modifying or waiving the adopted
standards if EPA determines that an
alternative (partial or modified) set of
standards or pre-existing requirements
achieves a level of safety that is at least
equal to that specified in the adopted
requirements.
3. Changes. The same general
approach that was described in the 1999
supplemental notice is included in the
final regulations. The final rule refers to
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and adopts some DOT standards for
pesticide products that are not DOT
hazardous materials and requires that
these products be packaged in
containers that are designed,
constructed, and marked to comply with
the adopted requirements for Packing
Group III materials. However, a number
of changes are made in the final rule
approach:
• The biggest change is related to the
changes in the scope of the nonrefillable
container standards. Rather than
completely exempt the lower risk
pesticide products (e.g., lower toxicity
in small containers without an
environmental hazard statement on the
label), the final rule mandates that the
lower risk products must comply with
the general packaging requirements in
49 CFR 173.24.
• Some of the specific 49 CFR
standards that are adopted for the higher
risk products in nonrefillable containers
and for all products in refillable
containers are different in the final rule
than in the supplemental notice
approach. In particular, the final
regulations include an exception from
49 CFR 173.28(b)(2), which requires
leakproofness testing every time a nonbulk packaging is refilled. The final
regulations specify that this
leakproofness testing is not required for
products that are not DOT hazardous
materials if containers comply with the
40 CFR part 165, subpart C regulations
and the repackaging is done in
compliance with the 40 CFR part 165,
subpart D regulations. Also, the final
rule refers to and adopts only portions
of 49 CFR 173.240 and 173.241 (bulk
packaging for certain low hazard
materials) to clarify that the pesticide
container regulations do not regulate
transport vehicles. By referring to and
adopting only paragraphs (c) and (d) in
both sections, the final rule incorporates
the standards for portable tanks, bulk
bins and intermediate bulk containers,
but not for rail cars, motor vehicles or
cargo tanks.
• The final regulations specifically
refer to and adopt the terms of the
exceptions for Class 9 miscellaneous
materials in 49 CFR 173.155 instead of
incorporating the relevant text from that
section into the pesticide container
regulations, as discussed in the
supplemental notice.
4. Comments on the overall approach.
More than 20 respondents commented
on the approach of adopting some DOT
requirements at the Packing Group III
level in the supplemental notice. The
comments can be split into two
categories according to the type of
commenter. State regulatory agencies
and agricultural pesticide registrants
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47351
and registrant groups generally
supported the overall approach, while
registrants and registrant groups from
the non-agricultural pesticide sector
generally opposed the overall approach.
i. Support. Several State regulatory
agencies and an agricultural registrant
group supported EPA’s approach of
adopting some DOT requirements for
pesticide products that are not DOT
hazardous materials. These commenters
stated that consistency with DOT
should facilitate compliance and
minimize confusion in the regulated
community and will avoid conflicting
regulations.
In addition, a few agricultural
registrant groups and some agricultural
registrants supported EPA’s overall
approach, if EPA incorporates the
changes included in their comments on
the supplemental notice. These
comments recommended changing
several sections of the DOT regulations
that are adopted and extending the
compliance period for refillable
containers. One of the registrants
commented that all pesticides in
nonrefillable containers should meet the
DOT PG III standards at a minimum to
provide an updated level of protection
for the environment and for all who use,
store, display, buy or distribute
pesticide products.
ii. Oppose. About 10 respondents
clearly opposed the supplemental notice
approach of adopting some DOT
Packing Group III standards for products
that are not DOT hazardous materials,
including several nonagricultural
registrant groups, a group representing
agricultural formulators and
distributors, an institutional formulator/
distributor group and some nonagricultural registrants. These
respondents opposed EPA’s approach
because they claim that:
• There is no need to regulate
pesticides that are not DOT hazardous
materials. Several commenters stated
that DOT requirements take into
consideration the seriousness of
transporting the substances and that
DOT chose not to regulate these
substances. Several others questioned
whether there is evidence of a problem
with shipping non-DOT hazardous
pesticides.
• Costs of packaging would increase,
which respondents state would be
burdensome for small businesses. Costs
mentioned were $2,500 for design plate
changes and about the same amount per
package type to maintain the required
certification files.
• This approach would be
burdensome for EPA to monitor DOT
regulatory changes and to render
exemption decisions. A commenter also
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questioned whether EPA had the
expertise to make exemption decisions.
• EPA’s approach would be confusing
because it incorporates some, but not
all, of DOT’s standards.
• EPA’s regulations could be different
than DOT’s. Several commenters cited
the waiver provision and the lack of a
consumer commodity exemption in
EPA’s approach as examples.
iii. EPA response. EPA continues to
believe that the general approach of
referring to and adopting the DOT
Packing Group III packaging design,
construction and marking requirements
is the best approach for regulating
pesticide containers.
Commenters who opposed this
approach in the supplemental notice
must recognize that the alternative to
the supplemental notice approach of
referring to and adopting some of DOT’s
standards is not an option of declining
to establish regulations for container
integrity and construction. Instead, as
described in the supplemental notice,
the alternative is to finalize the
standards from the 1994 proposed rule
that address container integrity and
construction. These standards include
container integrity and compatibility,
marking, and reclosing securely for
nonrefillable containers and container
integrity, marking and a drop test for
refillable containers. EPA is separately
required under FIFRA to promulgate
such regulations for all pesticides. If
Congress had believed that existing
Federal requirements promulgated by
DOT were sufficient, or that EPA should
restrict its regulation to pesticides
covered as DOT hazardous materials,
Congress could have restricted FIFRA
section 19 to that extent. Instead, it
appears that, with limited exceptions,
Congress intended all pesticides to be
regulated under section 19.
In fact, the approach to refer to and
adopt the DOT Packing Group III
packaging design, construction and
marking requirements was based on
suggestions from commenters on the
proposed rule, who urged EPA to be
consistent with the DOT regulations.
More than 20 respondents, including
individual companies and trade groups
from the pesticide registrant and
container manufacturing industries,
provided commentary on the DOT HMR
and the United Nations (UN)
Recommendations on the Transport of
Dangerous Goods. All of the
commenters agreed that EPA should be
consistent with the DOT HMR and the
UN standards in terms of definitions,
requirements, and testing. Respondents
argued that such consistency would: (1)
Facilitate compliance because the
industry is already familiar with the
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DOT and UN standards; (2) eliminate
the potential burden of complying with
two different, overlapping regulatory
schemes; and (3) not establish
additional trade barriers. Most of the
commenters on the DOT issue in the
proposed rule specifically favored the
use of DOT’s Packing Group III criteria
as the minimum standard for pesticide
products not regulated by DOT as
hazardous materials.
B. Leakproofness Testing Before Reuse
(49 CFR 173.28(b)(2))
1. Final regulations. The final
regulations retain the reference to 49
CFR 173.28, which establishes
standards for the reuse, reconditioning
and remanufacture of packagings. Also,
the final rule adds a provision that
exempts refillers from the leakproofness
test requirement in 49 CFR 173.28(b)(2)
for products that are not DOT hazardous
materials if the refillable container
complies with the refillable container
regulations and the refilling is done in
compliance with the repackaging
regulations.
2. Changes. The major change to this
part of the approach is that the final
regulations add a provision that
exempts refillers (which includes
registrants and independent refillers)
from the leakproofness test requirement
in 49 CFR 173.28(b)(2) for products that
are not DOT hazardous materials if the
refillable container is in compliance
with the subpart C refillable container
regulations and the refilling is done in
compliance with the subpart D
repackaging regulations. This exception
was added in response to comments on
the supplemental notice.
3. Comments. Some commenters including several registrant groups and
several registrants - opposed the
requirement in 49 CFR 173.28(b)(2) for
non-bulk packaging to pass a
leakproofness test before every time it is
refilled. The test involves applying a
raised internal air pressure to the
container and ensuring that no air leaks
from it. The test method for the
leakproofness test described in 49 CFR
178.604 specifies restraining the
container under water to determine if
air leaks from the container, although
alternatives are provided in an appendix
to part 178. The commenters generally
requested EPA to delete the reference to
49 CFR 173.28, although they did not
point out problems with any other
provisions of 49 CFR 173.28. One of the
registrants provided the most precise
and detailed description of the potential
problems that could result from
requiring leakproofness testing before
every refill, including:
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• It would pose practical problems
and increased costs because refillers and
possibly farmers would have to obtain
the training and equipment required to
do the leakproofness test.
• Due to the logistical and cost
problems, the registrant believes that
many non-bulk refillable containers
would be replaced by nonrefillable
containers, contrary to EPA’s stated
goals of pollution prevention.
• This commenter believes that the
general packaging requirements in 49
CFR 173.24 and the container
inspection provisions in subpart D of
EPA’s regulations are sufficient to
ensure the integrity of non-bulk
refillable containers.
• In addition to a leakproofness test,
49 CFR 173.28(b)(2) specifies a marking
requirement, which could be interpreted
to impose a testing requirement because
of other DOT provisions (such as 49
CFR 171.2(c)), even if the packaging is
used to transport only non-hazardous
materials. The commenter stated that
DOT provided a verbal interpretation
that 49 CFR 171.2(c) does not require
such testing of non-bulk containers used
to transport only non-hazardous
materials. The registrant recommended
that EPA consult with DOT to confirm
the approach on this topic. This
commenter and a few registrant groups
recommended deleting the reference to
49 CFR 173.28 to avoid confusion about
whether a container must be
leakproofness tested before it is refilled.
4. EPA response. EPA agrees with the
commenter’s concerns about the
problems that might be caused by
requiring a leakproofness test each time
a non-bulk refillable container is refilled
with a pesticide product that is not a
DOT hazardous material. However, EPA
disagrees with the commenters that the
solution is to delete the reference to 49
CFR 173.28. EPA believes that § 173.28
includes useful provisions that will help
ensure the safe reuse of pesticide
containers. In addition, § 173.28
includes provisions for reconditioning
and remanufacturing containers, which
will clarify and allow the reconditioning
of certain kinds of packaging, such as
drums. Many commenters on the
proposed rule and supplemental notice
identified the lack of a regulatory option
for reconditionable containers as an
issue. Including the reference to
§ 173.28 solves this problem and allows
drums to be reconditioned and then
reused under the pesticide container
regulations.
Rather than deleting the reference to
49 CFR 173.28, EPA is modifying the
final regulations to exempt refillers from
the leakproofness test requirement in 49
CFR 173.28(b)(2) for products that are
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not DOT hazardous materials if the
refillable container complies with the
refillable container regulations and the
refilling is done in compliance with the
repackaging regulations. This provision
is similar to one in DOT’s regulations,
specifically 49 CFR 173.28(b)(7), which
allows a package to be reused without
being leakproofness tested with air if
four criteria are met, including being
refilled and offered for transportation by
the original filler. EPA believes that the
refillable container requirements in
subpart C, including the adopted DOT
standards, and the repackaging
requirements in subpart D, including
the container inspection standards,
provide for the safe refill and reuse of
refillable pesticide containers without
requiring leakproofness testing before
each refill.
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C. Regulating DOT Intermediate Bulk
and Bulk Containers (49 CFR 173.240
and 173.241)
1. Final regulations. The final
regulations refer to and adopt only
certain paragraphs of the DOT
regulations that authorize bulk
packagings for certain low hazard
materials. In particular, the final
container rule refers to and adopts 49
CFR 173.240(c), 173.240(d), 173.241(c),
and 173.241(d), so it incorporates
standards for portable tanks, bulk bins
and intermediate bulk containers, but
not for rail cars, motor vehicles or cargo
tanks. DOT defines bulk packagings to
be larger than 119 gallons for liquids
and 882 pounds for solids.
2. Changes. The approach described
in the supplemental notice would have
incorporated all of 49 CFR 173.240 and
173.241. The final regulations were
changed to refer to and adopt only the
portions of those sections that authorize
portable tanks, closed bulk bins and
intermediate bulk containers (IBCs). The
portions of 49 CFR 173.240 and 173.241
that are not included in the final
regulations authorize rail cars, motor
vehicles and cargo tanks, which are not
regulated by the container regulations.
3. Comments - supplemental notice.
The comments from eight respondents
(registrants and registrant groups) were
split fairly evenly on this topic, even
though these commenters tended to
provide similar comments on other
parts of the approach to incorporate
some DOT regulations.
A few registrant groups and a
registrant (all from the agricultural
pesticide sector) supported the reference
to 49 CFR 173.240 and 173.241. These
respondents supported authorizing bulk
packagings by adopting these sections
for the following reasons:
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• DOT provides greater latitude on
the construction and less frequent
testing requirements for bulk packages
because of their size and sturdier
construction. EPA should follow the
same approach and authorize the same
standards for bulk containers used to
distribute pesticides that are not DOT
hazardous materials.
• These sections of the DOT
regulations authorize the use of certain
non-DOT specification bulk packaging,
including portable tanks and bulk bins.
A few of these commenters stated that
non-DOT specification packagings that
are authorized for DOT Class 9 materials
should also be acceptable for pesticides
that are not DOT hazardous materials.
The non-specification packagings must
comply with the general packaging
requirements in 49 CFR part 173, but
not all of the testing and marking
standards in other portions of the HMR.
In addition, the registrant explained
that the HMR do not require non-DOT
specification packagings (which are
authorized by 49 CFR 173.240 and
173.241) to have the UN symbol marked
on them. This commenter requested
EPA to confirm that the pesticide
container regulations authorize the use
of these non-DOT specification
packagings.
On the other hand, a non-agricultural
registrant group and several agricultural
registrants opposed the reference to 49
CFR 173.240 and 173.241. Several of the
registrants stated that the intent of their
comments on the proposed rule was for
EPA to adopt the DOT Packing Group III
standards for non-bulk packagings, not
for bulk containers (which includes
intermediate bulk containers by
definition). The registrant group stated
that the requirements in §§ 173.240 and
§§ 173.241 would be burdensome and
are not necessary from a safety
standpoint. This commenter also
believes that adopting these
requirements would lead to a decrease
in the use of refillable containers.
A registrant requested that EPA reevaluate the reference to these sections
because they authorize bulk and
intermediate bulk containers and the
definitions of these kinds of containers
are very different than the ones
customarily used within the agricultural
pesticide industry. A few other
commenters also addressed the
definition issue by pointing out that the
term minibulk (used in the agricultural
pesticide industry and in the proposed
regulations) has no DOT regulatory
definition.
4. EPA response - supplemental
notice. EPA is aware that the DOT
regulations do not include a definition
of minibulk container. However, the
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47353
proposed definitions for dry and liquid
minibulks were developed to
intentionally include container sizes in
both DOT’s non-bulk and intermediate
bulk container categories. As mentioned
above, under the DOT regulations,
intermediate bulk containers are a
subset of bulk containers. EPA is not
finalizing the definitions of dry and
liquid minibulk (and bulk) containers in
the final rule, as described in Unit V.
EPA intended to refer to and adopt
DOT Packing Group III packaging
standards for DOT non-bulk containers
and intermediate bulk containers. EPA
disagrees with the commenters who
support the DOT standards for non-bulk
containers (less than 119 gallons for
liquids or 882 pounds for solids) but not
for the next largest size, intermediate
bulk containers. Minibulk containers
used for pesticides include ones with
capacities in the non-bulk classification,
e.g., 60 to 110 gallons, and containers in
the intermediate bulk container sizes,
e.g., 150 to 250 gallons. EPA believes
that it is not logical to require smaller
minibulks to comply with the DOT
Packing Group III testing standards, and
to not specify any testing standards for
larger minibulks, which could lead to a
bigger spill. EPA believes strongly that
both non-bulk and intermediate bulk
containers holding pesticides that are
not DOT hazardous materials should
comply with the applicable Packing
Group III packaging construction,
testing and marking requirements.
Upon re-evaluation of the reference to
40 CFR 173.240 and 173.241, however,
EPA realized that there may be some
confusion caused by the paragraphs that
authorize rail cars, motor vehicles and
cargo tanks. EPA has never intended to
regulate transport vehicles. The
proposed rule (in § 165.122(b)(2)) and
the final rule (in § 165.43(h)) state that
the pesticide container regulations do
not apply to transport vehicles that
contain pesticide in pesticide holding
tanks that are an integral part of the
transport vehicle and that are the
primary containment for the pesticide.
To eliminate potential confusion, EPA
changed the final rule to only include
the portions of 49 CFR 173.240 and
173.241 that authorize portable tanks,
bulk bins and intermediate bulk
containers.
5. Comments - UN marking. In
response to the 2004 reopening of the
comment period, some commenters
provided new information and
comments regarding the approach of
referring to and adopting a subset of
DOT’s hazardous materials packaging
regulations. A registrant group and two
registrants commented that, since the
supplemental notice was published in
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1999, several manufacturers have
voluntarily changed their packaging
specifications for all products,
hazardous materials and nonhazardous
materials, to meet DOT Packing Group
III standards.
These three respondents and two
other commenters (a registrant group
and a registrant) supported the marking
that would be required by adopting the
DOT standards. One registrant group
stated that ‘‘It is important to have the
UN marks to provide a minimum
performance standard to those in the
channels of distribution that purchase,
fill, and sell crop protection products in
refillable containers.’’ The other
commenters also supported adopting
the DOT marking, but asked for
clarification about which containers
would need the UN mark. The DOT
regulations do not require UN markings
on certain kinds of containers, such as
non-DOT specification portable tanks
and containers holding limited
quantities or consumer commodities.
One of the registrants stated that their
understanding of the DOT reference is
that EPA is proposing UN markings only
for those kinds of containers that require
UN markings for DOT Packing Group III
hazardous materials. In other words,
when DOT regulations require UN
marking for a container holding a DOT
hazardous material, that same marking
would also be required for the same
kind of containers that hold pesticides
that are not DOT hazardous materials.
Most of the respondents recommended
adding a statement to the regulatory text
referring to the DOT regulations such as
‘‘This includes certain containers which
require UN markings (e.g., 2 x 2.5 gallon
cartons, 50 pound multiwall paper bags,
5, 30 and 55 gallon drums) and certain
other containers which do not require
UN markings (e.g., limited quantities,
consumer commodities and non-DOT
specification portable tanks).’’
On the other hand, a registrant group
and two registrants stated that the
marking size and location requirements
of 49 CFR 178.3 should not apply to
non-hazardous materials, claiming that
placing the UN mark on the containers
of these materials could create
confusion among carriers and
emergency responders. They expressed
concern that non-certified transporters
may refuse entire loads of nonhazardous materials marked with the
circle UN mark since this is an
indication of a DOT regulated material.
These commenters also said that
emergency responders may assume the
cargo is a hazardous material and
handle the situation accordingly if there
was an accident involving such
materials. These respondents suggested
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a certification process similar to Child
Resistant Packaging approval or placing
the specification packaging designation
for non-hazardous materials on the
product label (like the EPA Registration
Number) rather than the large and
prominent marking required by 49 CFR
part 178.
6. Response - UN marking. EPA wants
to clarify that the approach of referring
to and adopting a subset of the DOT
requirements would require the marking
that is specified in the DOT regulations.
UN markings would be required only for
those containers that require UN
markings for DOT Packing Group III
hazardous materials. If DOT does not
require the UN marking but allows the
use of the packaging for Packing Group
III materials (e.g., limited quantities,
consumer commodities and non-DOT
specification portable tanks), the EPA
regulations would allow the use of these
packagings and would not require the
UN marking. However, EPA is not
modifying the final regulations to add
the suggested additional sentence
because we do not believe it provides
additional clarification. In addition,
EPA believes that the preamble and
guidance documents are the proper
vehicles for providing this kind of
clarification. EPA disagrees with the
commenters who opposed using
containers with the UN mark for nonDOT hazardous materials. As other
commenters stated, several companies
have voluntarily switched to use DOT
Packing Group III (presumably with the
UN mark) since 1999 and have not
reported any of the potential problems
described by the respondents who
oppose using the UN mark. Further,
EPA clarifies that the UN mark would
only be required if required by the DOT
regulations.
D. Limited Quantity/Consumer
Commodity Exception (49 CFR 173.155)
1. Final regulations. The final
regulations refer to and adopt 49 CFR
173.155, which establish limited
quantity and consumer commodity
exceptions for Class 9 materials
(miscellaneous hazardous materials).
2. Changes. The potential alternative
regulatory text in the supplemental
notice would have incorporated the
relevant portions of the limited quantity
exception in 49 CFR 173.155 into the
text of the pesticide container
regulations. After reviewing the
comments and re-evaluating the
regulations, EPA believes it is more
straightforward to simply refer to and
adopt the entire section of the DOT
regulatory exceptions for Class 9
materials in 49 CFR 173.155.
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3. Comments. About 11 commenters
addressed the idea of including a
provision such as a limited quantity
exception in the pesticide container
regulations and all but one strongly
supported this kind of provision. The
opposing commenter, a registrant, stated
that it did not believe that incorporating
the Class 9 limited quantity exception
was appropriate. The other commenters,
mainly registrant groups and registrants,
varied a bit in the specific approach
they recommended, but all supported
the idea of including this kind of
exception in the pesticide container
regulations.
Several commenters specifically
requested that EPA add a reference to 49
CFR 173.155, the limited quantity and
consumer commodity exceptions for
Class 9 materials, to the pesticide
container regulations to be more
consistent with the DOT regulations.
Several respondents supported the
limited quantity exception as described
in the supplemental notice. Several
other commenters recommended that
EPA incorporate both the limited
quantity exception and the consumer
commodity exception in 49 CFR
173.155. As defined in the HMR,
consumer commodity means a material
that is packaged and distributed in a
form intended or suitable for sale
through retail sales agencies or
instrumentalities for consumption by
individuals for purposes of personal
care or household use. This term also
includes drugs and medicines. Two
registrant groups who urged EPA to also
adopt the consumer commodity
exception said that the consumer
commodity exception is necessary to
prevent increased costs and unnecessary
complications caused by complying
with EPA and DOT regulations that
would be different.
4. EPA response. As stated in the
supplemental notice, EPA continues to
believe that it is necessary to
incorporate a DOT limited quantity
exception to maintain consistency with
the HMR and to provide regulatory
relief for relatively small quantities of
pesticides. However, after reviewing the
comments and re-evaluating the
regulations, EPA believes it is better to
simply refer to and adopt 49 CFR
173.155 in its entirety because it is more
straightforward. In addition, the final
rule approach adds the benefit of
including the consumer commodity
exception for Class 9 materials, which
will provide clarity and consistency for
registrants of products that are not DOT
hazardous materials and that meet
DOT’s definition of consumer
commodity.
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E. Waiving or Modifying the
Requirement to Comply with Some DOT
Regulations (§§ 165.25(g) and 165.45(g))
1. Final regulations. The final
regulations include provisions that
would allow EPA to modify or waive
the requirements of the regulatory
sections that refer to and adopt the DOT
requirements if EPA determines that the
alternative (partial or modified) set of
standards or pre-existing conditions
achieves a level of safety that is at least
equal to that specified in the
requirements of this section. Section
165.25(g) establishes the waiver/
modification standard for nonrefillable
containers and § 165.45(g) provides it
for refillable containers.
2. Changes. This is the same basic
approach that was described in the
supplemental notice. EPA made a few
adjustments in the final regulations,
such as clarifying that EPA must
determine that the alternative set of
standards achieves an acceptable level
of safety before a waiver is granted
(rather than being based on the
registrant submitting information.) In
addition, EPA reorganized the final
regulations so all of the waiver requests
are grouped together to simplify the
process of applying for a waiver from
any of the container standards. Finally,
EPA changed the wording of the
regulations to clarify that, for pesticide
products that are DOT hazardous
materials, we will modify or waive the
requirements regarding the DOT
standards only after consulting with
DOT to ensure consistency with DOT
regulations and exemptions.
3. Comments - DOT regulations. Some
commenters (registrant groups and
registrants) supported the DOT waiver
provision set out in the potential
alternative regulatory text in the 1999
supplemental notice, stating they
believed it was sufficient. A few
registrant groups opposed the suggested
DOT waiver provision in the
supplemental notice. In particular, these
commenters opposed EPA modifying
DOT’s standards for pesticides subject
to DOT standards, because these
pesticides could be rendered out of
compliance with DOT standards and
could not be transported legally. One of
these commenters also expressed
concern about EPA’s ability to make
waiver decisions, questioning EPA’s
resources, lack of expertise similar to
DOT’s, and the absence of the kinds of
relationships that DOT has with
transportation-related standard setting
organizations.
4. EPA response - DOT regulations.
EPA understands some of the concerns
expressed by commenters regarding
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pesticides that are DOT hazardous
materials. It is possible that EPA
modifications to the adopted DOT
requirements for a pesticide that is a
DOT hazardous material could create a
set of requirements that conflict with
DOT’s regulations. In this case, it would
not be possible to package a pesticide
such that it could meet both EPA’s and
DOT’s standards. To prevent this kind
of situation, EPA modified the final
regulation in several ways. First, a
separate waiver provision is included
for pesticides that are DOT hazardous
materials and for pesticides that are not
DOT hazardous materials. Second, the
waiver provision for pesticides that are
DOT hazardous materials specifies that
EPA will modify or waive the
requirements only after consulting with
DOT to ensure consistency with DOT
regulations and exemptions. A similar
provision is not necessary for pesticides
that are not DOT hazardous materials,
because these pesticides aren’t subject
to DOT’s requirements, so there won’t
be a conflict.
EPA plans to coordinate with DOT as
much as possible and hopes to benefit
from their great experience in regulating
packaging and their relationships with
other organizations. EPA is very familiar
with regulating pesticides. Through our
authority in FIFRA to regulate pesticide
products (which includes the pesticides,
the labeling and the containers), we
have directly or indirectly set packaging
standards for a number of pesticide
products. We also have established
relationships with pesticide
manufacturers and have developed
expertise with pesticide handling and
use practices. It is possible that at some
point, compliance with one of the
adopted DOT standards may conflict
with safe use and handling practices for
pesticides. For pesticides that are not
DOT hazardous materials, EPA believes
we should have the ability to modify or
waive the adopted DOT standards if we
determine (based on information
provided) that an alternative set of
standards achieves a level of safety that
is at least equal to that specified in the
adopted DOT standards.
F. Providing Public Notice of Changes in
the Adopted DOT Regulations
(§§ 165.25(c) and 165.45(c))
1. Final regulations. The final
regulations include a provision that says
EPA will provide notice to the public in
the Federal Register, and an
opportunity to comment, if DOT
proposes to change any of the
regulations that are referred to and
adopted in EPA’s pesticide container
regulations. Following notice and
comment, EPA will take final action
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regarding whether or not to revise its
rules, and the extent to which any such
revision will correspond with revised
DOT regulations.
2. Changes. This is similar to the
approach described in the supplemental
notice.
3. Comments. A registrant group
questioned whether OPP has the
resources for the on-going effort of
monitoring DOT’s regulatory changes
and constantly proposing and
promulgating its own revisions to mirror
the DOT actions. This respondent also
expressed concern that there would be
lag times between DOT’s and EPA’s
regulatory changes, creating confusion
and putting registrants in the position of
being subject to conflicting Federal
standards.
4. EPA response. EPA does not
believe that the notification process in
the pesticide container regulations will
be overly burdensome. An OPP staff
member currently monitors the DOT
regulatory changes. Increased
communication with DOT resulting
from these final regulations should
provide advanced notice of any changes,
which would make any monitoring
efforts even easier. In addition, EPA
believes the commenter misunderstood
the point of this notification provision.
EPA does not anticipate changing its
regulations based on proposed changes
by DOT in most situations. Instead, the
purpose of EPA’s notifications will be to
let EPA’s regulated community know
that DOT has proposed to modify the
DOT regulations adopted by the
pesticide container regulations.
Therefore, pesticide registrants and
related parties will be able to monitor
the DOT rule process themselves and
can provide comments to DOT if they
believe it is warranted. If a DOT rule
change creates a significant obstacle to
compliance or another substantial
problem for pesticide containers, EPA
would consider changing the pesticide
container regulations that refer to and
adopt the DOT requirements. However,
EPA believes the chances of this
happening are very small because it
defeats the purpose of referring to and
adopting the DOT requirements to
provide a consistent set of packaging
requirements.
V. Nonrefillable Container Standards
A. Purpose (§ 165.20(a))
1. Final regulations. The purpose of
the nonrefillable container standards is
to establish design and construction
requirements for nonrefillable
containers used for the distribution or
sale of some pesticide products.
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2. Changes. This is nearly the same as
the proposed purpose (in § 165.100).
One minor change was to acknowledge
the reduced number of products that are
subject to the final regulations by stating
that the rule applies only to the
distribution or sale of some pesticide
products. The proposed regulations
would have applied to all products.
Another modification was to delete the
term ‘‘standards’’ from the phrase
‘‘establish standards and requirements’’
because it is redundant.
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B. Who Must Comply (§ 165.20(b))
1. Final regulations. You must comply
with the nonrefillable container
regulations if you are a registrant who
distributes or sells a pesticide product
in nonrefillable containers. If your
product is subject to the nonrefillable
container regulations as described in
Unit V.D., the product must be
distributed or sold in nonrefillable
containers that comply with these
regulations. This statement applies to
each and every nonrefillable container
used to sell or distribute the product.
2. Changes. This is the same approach
that we proposed in § 165.100. As
described in Unit V.D., the final rule
exempts some products from the final
rule and subjects some products to only
the basic DOT general packaging
standards. However, the approach of
registrants being responsible for
complying with the nonrefillable
container standards is unchanged.
C. Compliance Date (§ 165.20(c))
1. Final regulations. The final
regulations provide a 3–year period after
the date of publication of the final rule
in the Federal Register before
compliance with the nonrefillable
container standards is required.
Specifically, within 3 years from today’s
date, registrants must distribute or sell
all subject pesticide products in
nonrefillable containers in compliance
with these regulations.
2. Changes. EPA made several
significant changes to the compliance
date for nonrefillable containers in the
final rule. First, the final regulations
provide a 3–year period after today’s
date before compliance is required,
compared to the 2–year period in the
proposed rule. Second, the proposed
rule specified (in § 165.117(b)) that 5
years after the date of publication of the
final rule, all products distributed or
sold in nonrefillable containers by
persons other than the registrant would
have had to comply with these
standards. This ‘‘channels of trade’’ date
affecting persons other than the
registrant is not being finalized in
today’s final regulations. Third, the
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compliance date for registrants to
submit certifications is not being
finalized because the certification
requirement from the proposal is not
being finalized, as described in Unit
V.M.
3. Comments - length of compliance
period. About 15 commenters, including
registrants, registrant groups, a dealer
group, and a State regulatory agency,
stated that 2 years would not be enough
time to comply with the proposed
standards, especially the nonrefillable
container residue removal standard.
Many of the respondents commented
that 2 years is not long enough to test
containers initially and, for containers
that fail the residue removal standard, to
redesign containers, reformulate the
product, or obtain EPA approval for a
waiver. Also, many commenters
expressed concerns about delays caused
by EPA in providing necessary
implementation information, processing
waiver requests, and reviewing
reformulated products.
4. EPA response - length of
compliance period. EPA agrees with
some of the commenters that a longer
compliance period will make it easier
for registrants to comply with the
nonrefillable container standards. To
facilitate compliance while trying to
minimize the impact on companies,
EPA lengthened the compliance period
for the nonrefillable container
requirements to 3 years. EPA believes a
3–year period is sufficient based on the
results of the economic analysis and
because some of the changes made to
the regulations facilitate compliance.
These changes include: (1) Some
products are completely exempt from
the nonrefillable container
requirements; (2) many products must
comply only with basic DOT
requirements, not the full set of
nonrefillable container requirements;
and (3) changes in the residue removal
requirement, discussed in Unit V.H.,
which reduce the burden of that
requirement.
5. Comments - channels of trade.
Some commenters — registrant groups
and registrants — urged EPA to delete
the channels of trade provision,
generally stating that current products/
containers don’t pose a large enough
hazard to justify the costs of a recall. A
few State regulatory agencies and a
container manufacturer requested
clarification of this requirement, i.e.,
who would be included and who would
be responsible for compliance and/or
disposition of ‘‘expired’’ products.
6. EPA response - channels of trade.
EPA is not finalizing the 5–year
channels of trade provision in the final
rule to minimize the disruption and
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burden of implementing the rule. EPA
does not believe that current products
and containers pose a large enough
hazard (compared to the containers that
would be used to comply with the
requirements) to justify the costs of
recalling them from retailers and
distributors to either repackage or
dispose of them. EPA believes that
setting a date for when products
distributed or sold by registrants must
comply is sufficient. Products that are
distributed and sold before this date can
adequately work their way through the
distribution system.
D. Pesticide Products Included
(§ 165.23)
1. Final regulations. As described in
detail in Unit III., only certain products
have to comply with the nonrefillable
container standards. MUPs, plantincorporated protectants, and certain
antimicrobial products are completely
exempt from the nonrefillable container
requirements. All other pesticide
products are subject to the nonrefillable
container regulations.
There are different tiers of regulation
for products that are subject to the
nonrefillable container regulations. A
product is subject to all of the
nonrefillable container requirements if
it satisfies at least one of the following
criteria:
• It meets the criteria of Toxicity
Category I.
• It meets the criteria of Toxicity
Category II.
• It is classified for restricted use as
set out in 40 CFR 152.160 - 152.175.
If a product does not satisfy any of
these criteria (and it is not an MUP,
plant-incorporated protectant or an
exempt antimicrobial), it must be
packaged in accordance with 49 CFR
173.24. These products do not have to
comply with any other nonrefillable
container requirements. However, if any
of these products are DOT hazardous
materials, they are separately obligated
under DOT regulations to comply with
all applicable DOT requirements. In
other words, nothing in EPA’s
regulations changes the requirements in
the DOT HMR for products that meet
DOT’s criteria for hazardous materials.
2. Changes. In the proposal, only
MUPs would have been exempt from
the nonrefillable container regulations
(in § 165.100). All other products would
have been subject to the standards. The
1999 supplemental notice discussed
regulatory options for exempting some
products (antimicrobials and nonantimicrobials) from the full set of
refillable container regulations and for
exempting certain antimicrobial
products from specific requirements.
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The criteria in the final rule for
exempting antimicrobials are somewhat
different from those we indicated as our
preferred approach in the supplemental
notice. The final rule exempts plantincorporated protectants. Also, the final
rule uses toxicity category and restricted
use product status to determine the
level of regulation subject to all
nonrefillable container requirements
compared to the basic DOT packaging
requirements rather than to determine
whether the product is subject to or
exempt from the nonrefillable container
regulations.
47357
Table 6 describes the provisions for
determining which pesticide products
are subject to which nonrefillable
container regulations and a brief
explanation of how (or if) this provision
changed from the proposal and/or the
supplemental notice.
TABLE 6.—CHANGES TO THE SCOPE OF THE NONREFILLABLE CONTAINER REGULATIONS
Regulatory Provision in the Final Rule
Changes
Manufacturing use products are exempt.
No change from proposed rule or supplemental notice.
Plant-incorporated protectants are exempt.
Plant-incorporated protectants would have been subject to the proposed rule. The regulations for plant-incorporated protectants were
finalized in 2001. We are exempting them from the final rule because of their unique nature.
Certain antimicrobial products are exempt.
Antimicrobial products would have been subject to the proposed rule.
The final rule implements an approach similar to option 1 in the
supplemental notice, although some of the details are different.
All other products are subject to the regulations as follows:1
Products in Toxicity Category I or II are subject to all of the nonrefillable container requirements.
No change from the supplemental notice approach.
Restricted use products are subject to all of the nonrefillable container
requirements.
This is different from the other two criteria discussed most thoroughly
in the supplemental notice, which were: (1) container capacity
equal to or larger than 5 liters or 5 kilograms and (2) having a
specified environmental hazard statement on the label of an outdoor use product.
All other products (those in Toxicity Category III or IV and that are not
restricted use products) must comply only with the basic DOT packaging requirements in 49 CFR 173.24.
This category of lowest regulation is different from the supplemental
notice in two ways. First, these products are subject to the basic
DOT requirements rather than being completely exempt from the
nonrefillable container regulations. Second, more products are in
this category of lowest regulation because there are fewer Toxicity
Category III or IV products subject to all of the nonrefillable container requirements in the final rule (restricted use products) than
under the supplemental notice (products in small containers and
outdoor use products with a specified environmental hazard statement on the label).
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1The rest of the changes focus on changes from the supplemental notice. All of these products would have been subject to the proposed rule
because the proposed rule would have applied to all products except for manufacturing use products.
E. DOT Standards (§ 165.25(a) - (c))
1. Final regulations. As discussed in
detail in Unit IV., nonrefillable
containers must comply with the DOT
Hazardous Materials Regulations that
are referred to and adopted into EPA’s
regulations. These incorporated
regulations establish requirements for
container design, construction and
marking.
2. Changes. This is a significant
change from the proposed regulation,
although the approach of referring to
and adopting a subset of the DOT
standards was discussed in detail in the
1999 supplemental notice. See Unit IV.
for a detailed discussion. As discussed
in Unit V.M., three of the proposed
requirements for nonrefillable
containers (container integrity, marking
the material of construction and
ensuring that the container recloses
securely) are not being finalized in the
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final rule because they were replaced by
equivalent DOT requirements.
F. Closures (§ 165.25(d))
1. Final regulations. A nonrefillable
container must have at least one of the
four closures listed below if it meets all
of the following criteria:
• The container is used to distribute
or sell a liquid, agricultural pesticide;
• The container is rigid;
• The capacity of the container is
equal to or greater than 3.0 liters (0.79
gal); and
• The container is not an aerosol
container or a pressurized container.
The four closures specified in the
regulations are:
• Bung, 2 inch pipe size (2.375 inches
in diameter), external threading, 11.5
threads per inch, National Pipe Straight
(NPS) standard.
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• Bung, 2 inch pipe size (2.375 inches
in diameter), external threading, 5
threads per inch, buttress threads.
• Screw cap, 63 millimeters, at least
one thread revolution at 6 threads per
inch.
• Screw cap, 38 millimeters, at least
one thread revolution at 6 threads per
inch. The cap may fit on a separate rigid
spout or on a flexible pull-out plastic
spout.
2. Changes. The scope of the
requirement for standardized closures is
unchanged from the proposal; it applies
to liquid agricultural pesticides in rigid
containers with capacities equal to or
greater than 3.0 liters. The closure
standard does not apply to aerosol or
pressurized containers. The final
regulation made several changes in the
dimensions and other specifications of
the closures based on comments and
additional research to accurately reflect
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the closures that are most commonly
used in the agricultural pesticide
industry. Also, the proposed provision
that would allow the use of nonstandard closures was moved to a
separate section of the final rule
(§ 165.25(g)) along with the other waiver
and modification provisions, as
described in Unit V.I.
G. Dispensing Capability - Glugging and
Dripping (§ 165.25(e))
1. Final regulations. A nonrefillable
container with a capacity of 5 gallons
(18.9 liters) or less, that is not an aerosol
or pressurized container or a spray
bottle, and that holds a liquid pesticide
must do both of the following:
• Allow the contents of the
nonrefillable container to pour in a
continuous, coherent stream.
• Allow the contents of the
nonrefillable container to be poured
with a minimum amount of dripping
down the outside of the container.
2. Changes. The final rule includes
several substantial changes from the
proposal. First, the dispensing
requirements in the proposed rule
would have applied to all nonrefillable
containers for liquid pesticides,
regardless of the size of the container.
The final rule only applies the
dispensing requirements to containers
that are less than 5 gallons (18.9 liters)
in size. This change was made in
response to the comments that said large
containers should not be subject to the
dispensing standards. Because these
standards are intended to minimize
exposure to pesticides when they are
poured from containers, EPA agrees that
the requirements should not apply to
containers that are too large to allow
their contents to be poured from them.
The dispensing requirements in the
final rule apply only to containers with
capacities of 5 gallons (18.93 liters) or
less, which we believe are the
containers that can be picked up and the
contents poured out.
Second, the final rule clarifies that,
like the nonrefillable container closure
requirement, the glugging and dripping
standards do not apply to aerosol
containers or pressurized containers.
The proposed dispensing requirements
would have applied only to liquid
pesticides, and the final rule maintains
this approach. EPA did not intend that
these requirements would apply to
aerosol or pressurized containers. The
proposed closure regulation specifically
excluded aerosols and pressurized
containers, so the lack of similar
language in the dispensing requirements
led some commenters to believe that
aerosol and pressurized containers are
subject to the dripping and glugging
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standards. To clarify our intent, EPA
modified the final rule to clearly state
that the dispensing standards do not
apply to aerosol containers and
pressurized containers. As mentioned
above, the dispensing standard is
intended to minimize exposure to
pesticides when they are poured from
containers, which is not how pesticides
are dispensed from aerosol or
pressurized containers.
Third, the requirement in the final
rule was modified to also exclude spray
bottles. During a review of products that
would be subject to the final regulation,
EPA realized that spray bottles should
also be exempt from the dispensing
requirements because the container
contents are sprayed out by a trigger
mechanism, rather than poured.
Fourth, the requirement regarding
dripping in the final rule specifies that
the contents of a container must be
poured with a minimum amount of
dripping, rather than no dripping as
proposed. Fifth, the dripping standard
was clarified to specify ‘‘dripping down
the outside of the container’’ to
distinguish this from when the pesticide
drips out of the container into its target
when the material is poured from the
container. Many commenters
(registrants, registrant groups, a grower
group, a container manufacturer, and a
State regulatory agency) supported
modifying this standard from
‘‘eliminating’’ dripping to ‘‘minimizing’’
dripping. Most of these respondents
commented that completely eliminating
dripping is impractical or impossible
and that the amount of pesticide on the
outside of the container is largely a
function of user care. EPA agrees with
the commenters that the proposed
standard of eliminating dripping is not
practical, particularly without a specific
testing procedure and considering the
significant role of user handling
practices in whether the containers drip.
Therefore, EPA is modifying the
dripping standard to minimize rather
than eliminate dripping. The structure
of the standard was revised to be similar
to the glugging standard so it would be
clear that the dripping standard applies
when the contents are poured from the
container. Finally, the requirement
refers to minimizing the amount of
‘‘dripping down the outside of the
container.’’ EPA believes this phrase
clarifies that the dripping that should be
minimized is the trickle or drops of
liquid on the container exterior; not the
last few drops of material or rinsate that
leave the container when the contents
are poured.
Lastly, the proposed standard for
reclosing securely is not being finalized
in the final rule, because there is an
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equivalent DOT standard that is being
adopted, as explained in Unit V.M.
H. Residue Removal (§ 165.25(f))
1. Overview—i. Final rule. Rigid
containers with capacities less than or
equal to 5 gallons for liquid
formulations or 50 pounds for solid
formulations holding dilutable
formulations must be capable of
attaining at least 99.99 percent removal
for each active ingredient when tested
using the EPA testing methodology.
Percent removal represents the percent
of the original concentration of an active
ingredient in the pesticide product
formulation when compared to the
concentration of that active ingredient
in an extra rinse following
administration of the triple rinse
procedure specified in the testing
methodology, i.e., in the fourth rinse.
All dilutable products in these smaller
rigid containers must be capable of
meeting the 99.99 percent removal
standard, although the testing must be
done only if products are flowable
concentrate formulations or if EPA
requests the test data on a case-by-case
basis.
ii. Changes. EPA made many
substantive changes to the nonrefillable
container residue removal standard in
the final rule based on public comments
and a re-evaluation of currently
available data. The significant changes
are listed briefly in this subsection and
are described in more detail below in
the response to comment summaries.
The major changes in the residue
removal standard are:
• The performance standard was
changed from 99.9999 percent removal
(‘‘six 9’s’’) in the proposal to 99.99
percent removal (‘‘four 9’s’’) in the final
rule.
• The wording was changed from
‘‘The registrant shall demonstrate for
each container/formulation combination
that the standard is achieved’’ in the
proposal to ‘‘Each container/formulation
combination must be capable of
attaining the standard.’’ The language in
the final rule provides more flexibility
in showing compliance with the
standard, while still placing the
responsibility of meeting the standard
on the registrant.
• Testing (and the corresponding
recordkeeping in § 165.27(b)(5)) is only
required for flowable concentrate
formulations or if EPA specifically
requests the records on a case by case
basis.
• The test procedure will be
established as an OPP test procedure
titled ‘‘Rinsing Procedures for Dilutable
Pesticide Products in Rigid Containers,’’
which is incorporated into the
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regulations. (Ref. 20) The proposed
regulatory language provided some
details of the test procedure, which EPA
intended to supplement with guidance.
The final rule does not include the
specific testing requirements because
we believe it is more appropriate to
provide these detailed procedures in a
test protocol rather than in the
regulations.
• The residue removal standard only
applies to containers that are small
enough to be shaken because the final
test procedure and the supporting data
involved shaking the containers during
triple rinsing. As stated in Unit IX.I.,
EPA generally believes that the largest
containers that users can shake during
a triple rinse are those with capacities
of 5 gallons for liquids and 50 pounds
for solids.
In addition, the final residue removal
test procedures, incorporated in
‘‘Rinsing Procedures for Dilutable
Pesticide Products in Rigid Containers,’’
(Ref. 20) contain several key changes.
• In the final test procedure, the test
must be conducted on three containers,
rather than the proposed approach of a
minimum of 19 containers.
• Rather than the proposed statistical
standard (at least 95 percent confidence
that at least 85 percent of containers
tested will meet the standard), the final
test procedure specifies that all three
containers tested must meet the four 9’s
standard in the final rule. The final rule
approach is similar to the standards for
complying with DOT’s drop tests and
other performance tests.
• The final rule does not specify that
the testing must be conducted in
compliance with the full set of Good
Laboratory Practice Standards in 40 CFR
part 160. While registrants may comply
with the GLP standards, it is not
required. However, some key GLP
requirements are specified in the final
test procedure to accomplish the goals
of ensuring adequate quality of the
testing and the resulting data.
iii. Comments. Several State
regulatory agencies and a container
manufacturer group supported EPA’s
proposal to require a laboratory
standard for removing residue from
nonrefillable containers. These
commenters stated that such a standard
would enhance safe use and recycling,
facilitate management of empty
containers and provide flexibility to
registrants.
A registrant and a registrant group
supported consideration of a residue
removal performance standard but
opposed the stringency of EPA’s
proposal. Additionally, a few registrants
commented that encouraging the use of
containers and formulations that
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facilitate residue removal is reasonable,
but did not support the proposed
standard.
Many respondents (from nearly all
commenter categories, but mostly the
pesticide registrant industry) opposed
the establishment of any numeric
standard for residue removal for the
following reasons (which are described
in more depth in the Response to
Comment document (Ref. 19)):
• EPA doesn’t demonstrate a
problem;
• Much of the information cited by
EPA isn’t relevant/applicable;
• The problem is that users don’t
rinse containers; not the container
designs; and
• The solution is educating users and
enforcing rinsing standards.
Many commenters specifically
opposed the six 9’s standard as too
stringent. These comments claimed that
the six 9’s standard is overly ambitious
and that the standard would be too
costly for the benefit obtained. In many
cases, commenters said the standard
would be impossible to achieve. While
some respondents acknowledged that
the six 9’s standard is technologically
feasible, they said it would not be
practical in application.
iv. EPA response. EPA believes that
ensuring adequate residue removal at
the user level to achieve the goal of
containers that can be safely managed
for disposal or recycling involves the
following steps:
(1) The use of container designs and
formulations that facilitate effective
residue removal;
(2) Defining proper cleaning
procedures;
(3) Educating users about proper
cleaning procedures;
(4) Motivating users to properly clean
containers; and
(5) Enforcing proper cleaning in the
field.
Problems and breakdowns can occur
with any of these steps. If problems do
occur, containers will not be adequately
clean when they are offered for disposal
or recycling. EPA acknowledges the
commenters’ point that much of the
problem with inadequately cleaned
containers lies with the fact that the
users don’t rinse them properly,
implying a breakdown in items 2, 3,
and/or 4. EPA believes that the label
standards associated with these
regulations establish proper and clear
cleaning procedures, as described in
Units IX.F. - IX.K. EPA agrees that it is
important and appropriate to dedicate
adequate resources to user education
and motivation and to enforcing the
rinsing standards. Additional efforts on
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these points will be discussed in Unit
V.H.5.
However, EPA still believes that the
first step in adequate container cleaning
- and a responsibility of the registrant is making sure that the containers can
come clean. Therefore, EPA is retaining
a residue removal performance standard
in the final regulations for rigid
nonrefillable containers with dilutable
formulations. Additional information
about the many variables observed in
more than 20 rinsing studies and about
the FIFRA Section 19 mandates is in the
Response to Comment document. (Ref.
19)
2. Numeric residue removal standard.
EPA decided to change the performance
standard from 99.9999 percent removal
(‘‘six 9’s’’) in the proposal to 99.99
percent removal (‘‘four 9’s’’) in the final
rule.
i. Comments. Several State regulatory
agencies and an environmental group
specifically expressed support for the
‘‘six 9’s’’ standard. One State regulatory
agency said their data show that 99.9999
percent removal is achievable under
field conditions. Another said that the
standard is achievable for most
containers, but not for flat-topped metal
cans — a container type it feels is not
suited for use with pesticides.
On the other hand, many commenters
opposed the proposed six 9’s standard,
stating that it was overly ambitious and
too burdensome. Specific comments
include:
• Almost 20 commenters, mostly
registrants and registrant groups,
objected to EPA’s interpretation of the
residue removal data and particularly
opposed EPA’s assessment that a level
of six 9’s was technologically
practicable.
• About 20 commenters (mostly
registrants and registrant groups) urged
EPA to base the standard on the risks
involved. Many of these respondents
commented that there is no risk analysis
showing that residues in existing
containers pose a theoretical or real
threat or that reaching a six 9’s standard
would substantially reduce this risk.
• Many commenters, including
registrants, registrant groups, State
regulatory agencies, a dealer and a
dealer group, questioned the costeffectiveness of the six 9’s standard.
• Some registrants who opposed the
six 9’s standard favored adopting a less
stringent four 9’s requirement. They
termed it more practical, in line with
industry expectations, and the only
achievable level of removal.
One registrant group provided
comprehensive comments during the
2004 reopening of the comment period
based on the Ag Container Recycling
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Council’s (ACRC’s) experience over the
past 10 years. This commenter
described ACRC’s efforts to assess and
control the risk from using the recycled
plastic and noted that, since ACRC’s
inception in 1992, there have been no
reports of incidents where public health
or safety has been compromised as a
result of exposure to the minimal
residues found in recycled plastic
pesticide containers. Further, ACRC’s
study indicated that the risk to human
health and the environment from
recycling emptied pesticide containers
that remove 99.99 percent of residue
from containers is within acceptable
levels for recycling.
This registrant group also stated that
ACRC’s experience with recycling clean,
rinsed one way pesticide containers for
more than a decade leads them to
believe that residue removal is an issue
of instructing applicators to triple or
pressure rinse containers immediately
after use. A registrant expanded on this
idea by stating that recent experience
with pesticide container collection
programs has shown substantial
improvement in the cleanliness of
incoming containers and that it has
become obvious that problems with
dirty containers are not caused by
product that is not able to be rinsed, but
by users who do not rinse, or do not
rinse in a timely manner. The registrant
contrasted this experience with EPA’s
focus in the proposed rule on ensuring
that products will rinse easily from their
containers, which seems to have been
based the reports of poorly rinsed
containers from early container
collection programs. The registrant said
that great strides have been made in the
growth of State container return/recycle
programs and in grower, applicator, and
user education since that period.
ii. EPA response. After considering
the comments, re-evaluating the residue
removal data and factoring in the
experiences of pesticide container
collection and recycling programs over
the past decade, EPA believes the
residue removal standard should be
revised from 99.9999 percent to 99.99
percent removal.
Of the many rinsing studies, four sets
of data were developed using a standard
testing procedure (similar to the final
test procedure) to test currently used
formulations and container designs.
Two sets of data focused on containers
and formulations typical of the
agricultural pesticide market and the
other two were intended to represent
containers and formulations in the
household, institutional and industrial
market. Table 7 summarizes the results
of these studies in terms of the standard
that the container/formulation would
meet based on the concentration of
active ingredient in the rinsate from the
fourth rinse.
TABLE 7.—ANALYSIS OF RESIDUE REMOVAL DATA
Number of Container/Formulations That Meet*
Total Cntr/Form Combinations Tested
Study Name
Four 9’s
Five 9’s
Six 9’s
Formulogics (agricultural) (Refs. 8
and 36)
19
19
17
13
NACA (triple rinse) (Refs. 15 and
39)
24
24
19
12
Subtotal: agricultural market
43
43 (100%)
36 (84%)
25 (58%)
Formulogics
(nonagricultural)
(Refs. 6 and 37)
29
29
26
16
7
6
4
1
36
35 (97%)
30 (83%)
17 (47%)
79
78 (99%)
66 (84%)
42 (53%)
CSMA (Refs. 35 and 77)
Subtotal: nonagricultural market
Total
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*Note: Some container/formulation combinations were tested on one container; others on two or three (identical) containers for that formulation. Formulations tested on more than one container were classified in the highest standard that all of the containers met. For example, a container/formulation would be classified as four 9’s if the results for the formulation in three containers were 99.9988, 99.9996 and 99.9995. For reference, the structure of the studies were: (1) Formulogics (ag): all 19 tests on 1 container; (2) NACA (triple rinse): 9 tests on 1 container, 15
tests on 3 containers; (3) Formulogics (nonag): 3 tests on 2 containers, 6 tests on 3 containers but the rinsates had to be composited to provide
adequate volume, and 21 tests on 3 containers; and (4) CSMA: all 7 tests on 1 container.
While a more thorough discussion of
these data and the comments regarding
them is included in the next section,
EPA believes that the data show that a
standard of four 9’s adequately
represents the results from a careful
laboratory triple rinse. Of the 79
container/formulations tested, only one
did not meet a 99.99 percent removal
standard. The Consumer Specialties
Manufacturers Association (CSMA, now
the Consumer Products Manufacturers
Association) provided information
indicating that the container/
formulation that failed was an
agricultural pesticide product in a
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household pesticide container.
Therefore, EPA does not believe that
this data point represents a formulation/
container that is actually distributed in
the marketplace. After reconsidering the
available data, EPA believes that the
proposed standard of six 9’s would be
a ‘‘technology-forcing standard,’’
whereas the final standard of four 9’s
accomplishes the goal stated in the
preamble of the proposed rule and
mandated in FIFRA section 19(f)(1)(B)
to establish a standard that is equivalent
to triple rinsing.
EPA also considered the experiences
and results of pesticide container and
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recycling programs over the past
decade. When the regulations were
proposed, the experiences and
observations of some of the earliest
container collection and recycling
programs were available. This
information led to the statement in the
preamble of the proposed rule that
‘‘Pesticide container recycling programs
and municipal waste facilities report the
frequent rejection of certain pesticide
formulation and container combinations
because of unacceptable pesticide
residues.’’ The data from some of the
earliest container collections are shown
in Table 8.
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47361
TABLE 8.—RESULTS FROM EARLY PESTICIDE CONTAINER COLLECTION PROGRAMS (REF. 43)
Number of Containers
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State
Year
Accepted
Rejected
Brought
In
Rejection
Rate
(percent)
Reference
Florida (South Florida)
1991
1,594
231
1,825
12.7
(Ref. 4)
Florida (Jackson County)
1991
991
113
1,104
10.2
(Ref. 3)
Illinois
1993
57,086
3,451
60,537
5.7
(Ref. 2)
Iowa
1990
64,000
ND
ND
50
(Ref. 9)
Michigan
1992
18,959
2,990
21,949
13.6
(Ref. 12)
Minnesota
1990
9,192
2,136
11,328
18.9
(Ref. 17)
Minnesota
1991
56,928
4,646
61,574
7.5
(Ref. 17)
However, more recent information
provided by several States shows that
the container rejection rate decreases
over time. This is generally attributed to
pesticide users becoming more aware of
proper rinsing procedures and the
container cleanliness standards because
of outreach, training and education
efforts. One example is the decrease in
the rejection rate experienced in
Minnesota from 1990 (18.9 percent) to
1991 (7.5 percent) despite a large
increase in the number of containers
collected, as shown in Table 8. Out of
the five Minnesota counties that had
programs both years and for which data
are available (Ref. 17), the rejection rate
in four of them decreased substantially
in 1991 while one stayed constant:
• Isanti County: The rejection rate
decreased from 20.9 percent in 1990 to
12.9 percent in 1991;
• Polk, Pennington and Red Lake
Counties: 9.5 percent in 1990 to 2.3
percent in 1991;
• Pope County: 13.8 percent in 1990
to 14.1 percent in 1991;
• Stevens County: 25.0 percent in
1990 to 0.2 percent in 1991; and
• Swift County: 14.6 percent in 1990
to 2.7 percent in 1991. (Ref. 17)
A 1996 report from the Minnesota
Department of Agriculture confirms that
this trend continued over time. (Ref. 13)
From 1990 through 1995, the container
rejection rate in Minnesota ranged from
10 percent to 20 percent, with a high of
35 percent. The report stated that
‘‘Pesticide users had a difficult time
rinsing containers to acceptable
standards. Timing of the rinse, poor
equipment for rinsing and inadequate
rinsing techniques resulted in many
containers not being accepted.’’ The
rejection rate for 1996 ranged from 0
percent to 2 percent.
Before 1995, a county in North
Carolina collected about 2,500
containers per year and had a container
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rejection rate around 28 percent. After
receiving a grant in 1995 which allowed
the county to expand the program to 12
convenient sites and to provide
additional training on proper rinsing,
the county collected about 21,000
containers and the rejection rate
dropped to 3 percent. (Ref. 10) Nebraska
and South Carolina report current
rejection rates of 2 percent on their web
sites. Virginia reported a rejection rate
of 0.5 percent in 2002, which was
higher than the 2000 rate but still
deemed to be acceptable. (Ref. 43)
EPA believes this information shows
that the main reason containers are
rejected from pesticide container
collection programs is because they
were not rinsed properly. EPA agrees
with the States that the container
rejection rates decreased substantially
over time as pesticide users improved
their rinsing techniques, rinsed the
containers before residue dried, and
gained understanding of the cleanliness
criteria used by the Ag Container
Recycling Council (ACRC) recycling
contractors. The ACRC contractors have
a strong incentive to carefully inspect
containers to ensure they are clean
because contamination increases the
risk to the contractor’s workers and
reduces the value of the collected
plastic. Therefore, we think it is
accurate to conclude that the lower
rejection rates in recent years are not a
reflection of relaxed or reduced
inspection standards.
EPA also believes that the container
rejection rates from the container
collection and recycling programs show
that containers do not have to meet a
standard of six 9’s to be adequately
cleaned. Table 7 shows that almost 60
percent of the agricultural formulations
and containers tested met a standard of
six 9’s. Assuming that the tested
formulations/containers are
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representative of the agricultural
market, we would expect to find a
rejection rate of over 40 percent if a six
9’s standard was necessary for adequate
cleaning. Data from several States show
that currently a maximum of 2 percent
of containers are rejected, which is
much lower than 40 percent. EPA
interprets this to indicate that meeting
a standard of six 9’s is not necessary to
ensure that a container is clean enough
to be recycled safely.
EPA disagrees with commenters who
stated that the residue removal standard
should be based solely on toxicological
significance, because establishing and
proving compliance with such a
standard would be very complex. In
addition, any amount of residue in a
container could cause a disruption to its
proper disposal or recycling because of
the perception of risk the concentration
of active ingredient may not be relevant
in such a situation. However, toxicity
and relative risk are indirectly taken
into account for the nonrefillable
residue removal standard in the final
rule because of the changes in the scope
of the container regulations. The less
toxic/risky pesticide products (those in
Toxicity Categories III and IV and that
are not restricted use pesticides) are
subject only to the basic DOT standards,
and are exempt from some of the
container requirements, including this
one. Only products that are in Toxicity
Category I and II and others that are
restricted use products are subject to the
residue removal standard in the final
rule.
Setting the residue removal standard
at four 9’s in the final rule will reduce
the costs of implementing the
regulations because a higher percentage
of existing container/formulations will
comply with the standard. Therefore,
fewer container design changes, reformulations, and modification or
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waiver requests will be needed.
Reducing the stringency of the residue
removal standard does not reduce the
testing costs. However, the testing costs
attributed to the final rule are reduced
from those in the proposal because
fewer containers/formulations are
subject to the standard (due to the
changes in the scope). In addition,
changes in the final test procedure (see
Unit V.H.4.) and the final
implementation approach (discussed in
Unit V.H.5.) of only requiring testing for
flowable concentrate formulations and if
requested on a case-by-case basis will
greatly reduce testing costs.
EPA believes that a 99.99 percent
removal standard is consistent with the
results from triple rinsing current
containers/formulations, which we
generally believe can be adequately
cleaned if they are properly rinsed.
In summary, EPA believes that most
containers/formulations can meet a four
9’s standard. However, we do believe
that a standard is necessary and
appropriate for several reasons. First,
the initial step in ensuring clean
containers is to use container designs
and formulations that facilitate residue
removal. This is a responsibility of the
registrant and a standard ensures that
the registrants appropriately facilitate
safe and proper residue removal.
Second, the rinsing data show that there
is a difference in how easily residues
can be removed from containers, based
on the formulation and container
characteristics, meaning that there is the
potential for problems in removing
residues. Third, observations from State
pesticide container collection programs
have noted a problem over time (i.e., not
just when collections were initiated)
with certain pesticide formulations as
discussed in more detail in Unit V.H.5.
Lastly, a four 9’s standard maintains the
current level of rinsability and prevents
the use of formulations or containers
that retain more residue or are harder to
rinse than currently used containers and
formulations.
3. Rinsing data—i. Comments. Some
commenters specifically addressed the
triple rinsing data discussed in the
preamble of the proposed rule. A
registrant group and a registrant
questioned the relevancy of some of the
container cleaning data cited by EPA.
These respondents pointed out that
some of the data were 6 to 10 years old,
and cited a widespread move to plastic
jugs, making data on metal pails
obsolete.
Several commenters expressed the
following specific concerns about the
residue removal data that EPA cited to
support the proposed six 9’s standard:
• A registrant group and a registrant
commented that several transcription
errors were made in constructing Table
1 (triple rinsing data for agricultural
containers/formulations) in the
preamble of the proposed rule. One of
the respondents added that these errors
undermine the credibility of the data
and the arguments developed that use
the data as their basis.
• A registrant questioned whether the
research data were generated under
GLPs.
• Two registrants questioned whether
the data are truly representative of
containers/formulations that are subject
to the regulations.
• A registrant commented that data
other than EPA’s (Formulogics), NACA’s
and CSMA’s are not relevant because
they are not generated from the same
test procedures.
A registrant group and a few
registrants expressed concerns that the
EPA data for non-agricultural pesticide
markets (in Table 2 of the preamble of
the proposal) are not representative of
the household, industrial and
institutional markets. All of these
commenters pointed out that the EPA
data do not include tests on dilutable
antimicrobial products or similar
formulations. In addition, the registrant
group stated that EPA (Formulogics) did
not test formulations containing active
ingredient concentrations lower than 38
percent by weight. This respondent also
added that the data provided by CSMA
cover a small but representative number
of nonagricultural container/
formulation combinations and that most
of them (10 out of 12) would not meet
the six 9’s standard.
ii. EPA response. EPA agrees that
residue removal data produced using a
rinsing procedure other than the one
identified in the EPA standard
methodology are not relevant to
supporting or changing a regulatory
standard. As stated in Unit V.H.2., four
sets of data were developed using a
standard testing procedure (that is very
similar to the final test procedure) to
test currently used formulations and
container designs. Two sets of data
focused on containers and formulations
typical in the agricultural pesticide
market and the other two were intended
to represent containers and formulations
in the household, institutional and
industrial market. Even though the
testing to develop these four sets of data
was done in the early 1990’s, EPA
believes that the formulations and
containers tested are still commonly
used.
Table 7 presents the results of these
studies in terms of the standard that the
container/formulation would meet
based on the concentration of active
ingredient in the rinsate from the fourth
rinse. The following table presents the
information in a somewhat different
format. In Table 9, each container/
formulation combination is included
only once per row in the column for the
most stringent standard it would meet.
For example, if the percent removal for
a container/formulation combination
was 99.9992 percent, it would be listed
only in the five 9’s column (even though
it also meets a standard of four 9’s).
TABLE 9.—ANALYSIS OF RESIDUE REMOVAL DATA
Total
Cntr/Form
Combinations
Tested
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Study Name
Number of Container/Formulation Combinations That:1
Don’t meet Four
9’s
Meet Four 9’s
Meet Five 9’s
Meet Six 9’s
Formulogics (agricultural)
19
0 (0%)
2 (11%)
4 (21%)
13 (68%)
NACA (triple rinse)
24
0 (0%)
5 (21%)
7 (29%)
12 (50%)
Formulogics (nonagricultural)
29
0 (0%)
3 (10%)
10 (34%)
16 (55%)
7
1 (14%)
2 (29%)
3 (43%)
1 (14%)
79
1 (1%)
12 (15%)
24 (30%)
42 (53%)
CSMA
Total
1
Same note as Table 7.
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Looking at the presentation of the
results of the four studies in Tables 7
and 9, it can be seen that a higher
percentage of the container/
formulations tested by Formulogics for
EPA meet a standard of six 9’s than the
containers/formulations tested by the
industry associations. This is especially
true for the tests of nonagricultural
products. However, there is no
difference or minimal difference in the
results between EPA’s data and
industry’s data in terms of whether the
containers/formulations meet a standard
of four 9’s. As described earlier, only
one container-formulation combination
(which isn’t actually distributed in the
marketplace) did not meet a four 9’s
standard.
EPA acknowledges that there were
discrepancies between the data in the
Report to Congress and the data in Table
1 in the proposed rule’s preamble.
These discrepancies were due to
corrections made to the NACA data
reported to EPA; the earlier (and
incorrect) data were presented in the
Report to Congress and the more recent,
correct data (which should have been
cited) were included in the preamble for
the proposal. Reference 42 explains
these discrepancies in more detail.
Tables 7 and 9 present the correct data.
EPA acknowledges that the sample
size of 79 container/formulation
combinations is relatively small, but we
believe that the formulation types and
container designs tested to produce the
data in Tables 7 and 9 are representative
of the formulations and containers that
are currently used. Some formulations
(such as dilutable sanitizers and
disinfectants) may be under-represented
numerically, since only the CSMA
testing included these kinds of
formulations. However, the CSMA tests
done on the dilutable sanitizers and
disinfectants show that these kinds of
products can attain a standard of four
9’s. Also, only a limited number of
antimicrobial products will be subject to
the container regulations (and therefore
the residue removal standard) based on
the revised scope of the final rule.
Therefore, the proportion of
antimicrobial product formulation types
that were tested may be similar to the
proportion that are subject to the
residue removal standard in the final
regulation.
The supporting data were not
generated according to GLPs.
Additionally, the supporting studies
were conducted on one, two or three
containers per formulation; not 19
containers. As described in Unit V.H.4.,
the methodology in the final rule was
changed to be consistent with the
supporting data.
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4. Final test protocol. Many
respondents commented on the
proposed testing methodology and
particularly its relationship to the
protocol developed for EPA by
Formulogics prior to proposing the rule.
Most of these comments are addressed
in the Response to Comment document,
although the comments regarding GLP
standards and the number of containers
tested are summarized below.
i. Comments - GLP standards. Many
commenters (registrants, registrant
groups, and a consultant) objected to the
GLP testing requirement as
unnecessarily burdensome,
substantially increasing the cost of
testing without increasing the validity of
the data. However, one respondent (a
consultant) commented that all studies
should be done under GLPs in some
form to ensure data quality. A registrant
group and a registrant suggested that it
would be sufficient to require a
company official to certify the data.
Several registrants commented that GLP
testing would force them to have
outside labs conduct the testing and
claimed that this would dramatically
increase the costs. One registrant said
that many container testing labs are not
familiar with EPA’s GLP regulations.
Another stated that because labs cannot
dispose of rinsate properly, they will
send it back to the registrants,
increasing costs and waste generation. A
registrant group and a registrant pointed
out that the data used to develop EPA’s
proposal were not generated under GLP
and asked that the GLP requirement be
dropped from the final rule.
ii. EPA response - GLP standards. EPA
changed the test protocol for the final
rule in several ways to address some of
the problems described by commenters.
First, the final rule does not specify that
the testing must be conducted in
compliance with the full set of GLP
standards in 40 CFR part 160. While
registrants may comply with the GLP
standards, it is not required. EPA
believes that the container residue
removal testing can adequately be
accomplished by registrants at their
facilities; the intent was not to have this
testing contracted to outside labs,
although a registrant may choose that
option.
While EPA does not believe that
compliance with the full GLP standards
in 40 CFR part 160 is necessary, we
think that it is necessary to incorporate
some of the key GLP requirements to
ensure that the data are of sufficient
quality. EPA reviewed the part 160
regulations and particularly the subset
of requirements specified in 40 CFR
160.135 for certain studies to determine
physical and chemical characteristics of
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pesticides. Of the subset of requirements
identified in 160.135, we identified
some requirements that residue removal
testing must meet. These GLP
requirements are identified in the final
test protocol. (Ref. 20)
iii. Comments - number of containers.
All of the many (nearly 20) commenters
(registrants, registrant groups and a
container manufacturer group) who
addressed this issue were opposed to
testing 19 containers per formulation/
container combination. Many registrants
and a registrant group urged EPA to
require testing of only three replicates of
each container/formulation
combination, rather than the proposed
19. A registrant group and a few
registrants suggested starting with three
and testing more if necessary to achieve
a predetermined level of statistical
significance. Commenters said testing of
19 containers is not statistically
justified, not cost effective, and not
necessary for achieving the data
requirements. Some of these
commenters pointed out that EPA used
only three containers to generate the
preamble data and asked why the same
standard is not sufficient for registrants.
iv. EPA response - number of
containers. EPA changed the test
protocol for the final rule to specify that
the test must be conducted on a
minimum of three containers, rather
than the proposed approach of a
minimum of 19 containers. The main
reason for changing the number of
containers that must be tested is that the
testing conducted to produce the data
supporting the residue removal standard
was conducted on three containers. The
supporting data was not conducted on
19 containers, so it is unclear whether
the available data could support a
standard based on testing 19 containers.
Upon re-evaluation, EPA agrees that the
test procedure used to produce the
supporting data and the test procedure
for the regulatory standard should be
very similar if not identical. In addition,
EPA believes that testing three
containers offers cost reduction benefits
including less time to actually conduct
the testing with one-sixth the number of
containers to be rinsed, one-sixth the
number of analyses that need to be
conducted, and one-sixth the amount of
rinsate that needs to be managed or
disposed. The final rule approach of
testing three containers is similar to the
standards for complying with DOT’s
drop tests and other performance tests.
5. Implementation—i. Comments. In
the preamble of the proposed rule, EPA
requested comments on the
circumstances under which submission
of residue removal data from pesticide
products with substantially similar
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container/formulation characteristics
would be sufficient in lieu of data
generation for every pesticide product.
EPA also requested comments on the
factors to be considered in determining
when container and formulation
characteristics should be considered
‘‘substantially similar’’ for the purposes
of this requirement. The following
comments address these issues:
• Too many tests required: Some
respondents, including registrants,
registrant groups, and a container
manufacturer group, expressed concern
that the proposed residue removal
standard and the interpretation of
design type as expressed in the
proposed rule would necessitate testing
for virtually every container/
formulation combination in every size
and variation. They said the costs to
registrants would be crippling and
asked EPA to consider alternatives.
• Design type clarification: Several
commenters asked for clarification of
EPA’s criteria for determining whether
containers are the same or different.
They urged a broad definition of design
type to reduce the testing burden.
• Formulation similarities: Several
commenters suggested ways to
eliminate duplicative testing on the
basis of formulation, such as granting
waivers to products that meet certain
physical property criteria or to
formulations similar to ones that have
already passed.
• Industry task force: Some
agricultural registrants and a registrant
group voiced support for a plan to
establish an industry task force that
would conduct studies to determine the
physical properties of formulations and
containers that meet the four 9’s
standard. Combinations matching those
criteria would be exempted from testing;
necessary testing would be limited to
broad categories of product/container
combinations developed by the studies.
ii. EPA response. Many of the changes
in the residue removal standard
discussed in the previous sections
reduce the cost of complying with this
standard, including:
• Changing the scope of the
nonrefillable container regulations so
only dilutable products in Toxicity
Category I or II or that are restricted use
products have to comply with the
residue removal standard;
• Reducing the standard from 99.9999
percent to 99.99 percent removal; and
• Changing the testing protocol.
Despite these changes, the estimated
costs of complying with the residue
removal standard were still a fairly large
percentage of the overall annual costs
and costs per facility. Rather than trying
to minimize the burden to registrants by
trying to identify and define
substantially similar containers and
formulations, EPA believes it is better to
require testing only for formulations and
containers that have shown to be
difficult to clean. As stated earlier, EPA
believes the data show that most
containers/formulations can meet a four
9’s standard although practical
experience with container recycling
programs shows that there are problems
with certain formulations. Because a
universal approach (testing all products
subject to the regulations) to identify the
exceptions (the problematic
formulations) is inefficient, EPA
believes there is a more efficient yet
effective way to implement the residue
removal standard in the final
regulations.
In particular, the final rule takes the
following approach:
• All dilutable liquid products in
rigid containers must be capable of
meeting the 99.99 percent removal
standard. This sets a minimum standard
for all products.
• On the basis of the Formulogics and
NACA data, EPA is making the
assumption that nearly all products
meet a standard of 99.99 percent
removal, and therefore is requiring
testing only in limited circumstances. In
particular, registrants only have to
conduct the residue removal testing if
the products are flowable concentrate
formulations or if EPA requests the test
data on a case-by-case basis.
• Accordingly, the recordkeeping
standards in § 165.27(b)(5) were
changed so recordkeeping of test results
is only required for flowable concentrate
formulations or if EPA specifically
requests the records on a case-by-case
basis.
EPA chose to require testing of
flowable concentrate formulations for
several reasons. First, the results of the
four studies in Table 7 show that there
is a difference in rinsing efficiency
between the formulation types that were
tested, specifically flowable
concentrates, emulsifiable concentrates,
aqueous solutions, and encapsulated
formulations. Tables 10, 11, and 12
show the data from the studies in Table
7 with the residue removal performance
broken down by formulation type. The
results - particularly for the studies with
the most testing - show that flowable
concentrate formulations had the biggest
difference between meeting four 9’s and
five 9’s, which suggests that these kinds
of products may generally be a little
more difficult to remove from containers
due to characteristics of the formulation
type in general. The emulsifiable
concentrates tested generally reached a
five 9’s level of residue removal but
showed a similar difficulty as flowable
concentrates in reaching the six 9’s level
of residue removal in the Formulogics
study of agricultural formulations and
containers. While not completely
conclusive, EPA believes these data
support the observation that flowable
concentrates may generally be more
difficult to remove from containers than
other kinds of formulations.
TABLE 10.—ANALYSIS OF RESIDUE REMOVAL DATA BY FORMULATION TYPE - AGRICULTURAL FORMULATIONS AND
CONTAINERS (FORMULOGICS & NACA)
Total Cntr/Form
Combinations
Tested
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Formulation
Number of Containers/Formulations That Meet:
Four 9’s
Five 9’s
Six 9’s
Flowable concentrate
15
15
11
10
Emulsifiable concentrate
20
20
18
12
Encapsulated
4
4
3
1
Aqueous Solution
3
3
3
1
Dry Flowable
1
1
1
1
43
43
36
25
Total
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47365
TABLE 11.—ANALYSIS OF RESIDUE REMOVAL DATA BY FORMULATION TYPE—HOUSEHOLD, INDUSTRIAL AND INSTITUTIONAL
CONTAINERS (FORMULOGICS)
Total Cntr/Form
Combinations
Tested
Formulation
Flowable concentrate
Total
Four 9’s
Five 9’s
Six 9’s
10
10
7
1
9
9
9
8
10
10
10
7
29
29
26
16
Emulsifiable concentrate
Encapsulated
Number of Containers/Formulations That Meet:
TABLE 12.—ANALYSIS OF RESIDUE REMOVAL DATA BY FORMULATION TYPE—HOUSEHOLD CONTAINERS (CSMA)
Total Cntr/Form
Combinations
Tested
Formulation
Number of Containers/Formulations That Meet:
Four 9’s
Five 9’s
Six 9’s
Flowable concentrate1
1
1
1
0
Emulsifiable concentrate1 2
2
1
0
0
Aqueous solution1
4
4
3
1
7
6
4
1
Total
1
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Based on the description of the formulations, we assumed that the CSMA data included one flowable concentrate, two emulsifiable concentrates and four aqueous solutions.
2 The container/formulation that did not meet four 9’s was an agricultural emulsifiable concentrate in a small (16 ounce) container.
Second, the Minnesota Department of
Agriculture (DOA) developed a report
that summarized the observations of
inspectors and the experiences of
pesticide users regarding rinsing
containers that held pesticide products
formulated as flowable concentrates.
(Ref. 18) These containers tended to be
rejected at a higher rate than other types
of formulations. The Minnesota DOA
observed that about 60 percent of the
containers of one specific flowable
concentrate formulation contained
pesticide residue, even when the overall
container rejection rate at the collection
site was less than 1 percent. To make
the containers holding the studied
formulation come clean, users had to
take extra measures beyond triple
rinsing, such as power rinsing for a long
time, using hot water, cutting the
containers open to allow access to hardto-reach areas, soaking the containers,
using soap or another material and
conducting extra rinses. While we do
not have laboratory triple rinsing data
on this product to confirm whether or
not it meets a 99.99 percent standard,
the description in Minnesota’s report
clearly documents a problem with
cleaning the containers used for this
product, which was a flowable
concentrate. The Minnesota DOA report
mentioned several other products that it
also categorizes as more difficult to
rinse.
Third, recent conversations with
people active in pesticide container
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recycling confirmed commenters’
assertions that the main reasons for
unclean containers at recycling
programs are lack of effort by the end
users when rinsing containers and
because of pesticide product drying
along the inside of the container if the
material in the container is not used all
at once. (Ref. 26) Neither of these
problems would be addressed by the
residue removal standard. Based on
their observations, these people believe
that any container with any formulation
type can be adequately cleaned if the
container is emptied completely at one
time (all contents are used initially), if
the end user rinses the container
promptly after emptying it and if the
end user rinses it properly (either
pressure or triple rinsing). On the other
hand, these people also commented that
specific products may need a little extra
effort into rinsing (more time in a
pressure rinse or an extra rinse after the
triple rinse procedure) to completely
clean the container.
Based on this information, EPA
believes the final regulations should be
implemented in a way that minimizes
the required testing because the
laboratory data and field observations
do not support a widespread problem
with residue removal that could be
solved by the residue removal standard.
Therefore, EPA decided to only require
residue removal testing for flowable
concentrates, which showed the most
difficulty in being removed in the
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laboratory testing. EPA believes that the
field observations indicated that specific
products - in any formulation type - may
be more difficult to remove by rinsing
than other products. Therefore, the final
regulations also provide EPA the option
to require residue removal testing (and
keeping records of it) on a case-by-case
basis. EPA anticipates using this option
if we receive credible information about
a wide-spread problem with a specific
container/formulation combination
being difficult to clean.
I. Waiver and Modification Criteria
(§ 165.25(g))
1. Final regulations. Section 165.25(g)
of the final rule explains that registrants
may request waivers from or
modifications to the nonrefillable
container standards. This section sets
out the criteria that must be met for EPA
to approve a waiver/modification
request. The criteria are different for
each of the nonrefillable container
requirements, as described below.
• § 165.25(a): DOT standards for
pesticide products that are not DOT
hazardous materials. EPA may waive or
modify the requirements of § 165.25(a) if
EPA determines that an alternative
(partial or modified) set of standards or
pre-existing requirements achieves a
level of safety that is at least equal to
that specified in the requirements of
§ 165.25(a).
• § 165.25(b): DOT standards for
pesticide products that are DOT
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hazardous materials. EPA may waive or
modify the requirements of § 165.25(b)
if EPA determines that an alternative
(partial or modified) set of standards or
pre-existing requirements achieves a
level of safety that is at least equal to
that specified in the requirements of
§ 165.25(b). EPA will modify or waive
the requirements of § 165.25(b) only
after consulting with DOT to ensure
consistency with DOT regulations and
exemptions.
• § 165.25(d): Container closures.
EPA may approve a non-standard
closure (that is, a closure not listed in
§ 165.25(d)) if EPA determines that both
of the following conditions are satisfied:
(1) The non-standard closure is
necessary for the proper mixing,
loading, or application of the pesticide
product.
(2) The non-standard closure offers
exposure protection to handlers during
mixing and loading that is the same or
greater than that provided by the
standard closures.
• § 165.25(e): Container dispensing
capability. EPA may waive or modify
the standards in § 165.25(e) if EPA
determines that at least one of the
following conditions is satisfied:
(1) The product is typically removed
from the container by a method other
than pouring.
(2) Compliance with the container
dispensing capability standards would
increase exposure to the pesticide
container handler.
• § 165.25(f): Residue removal
standard. EPA may waive or modify the
requirements of § 165.25(f) if EPA
determines that both of the following
conditions are satisfied:
(1) The residue remaining in the
container would not cause an
unreasonable adverse effect on the
environment; and
(2) The product offers significant
benefits and cannot be economically
reformulated or repackaged.
2. Changes. The final rule is
significantly different than the proposal.
Additional waiver/modification
provisions were added and all of the
criteria were consolidated into one
section. The proposed rule included
waiver/modification provisions only for
the standard closure and residue
removal requirements. The waiver/
modification criteria for the standard
closure requirement in the final rule are
similar to the proposed regulations,
although a few minor editorial changes
were made. Also, the final rule clarifies
that both criteria must be met before
EPA will approve the use of an
alternative closure, which was the
intent of the proposed rule. The waiver/
modification provision for the residue
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removal requirement was modified to
add specific criteria that must be met.
This change was made partly because
the proposed criterion for waiving or
modifying the residue removal standard
was very broad and partly because a
more specific and limited waiver/
modification standard is appropriate
with the less stringent residue removal
standard in the final rule. The final rule
incorporates a DOT waiver provision
similar to the one set out in the
potential alternative regulatory text in
the 1999 supplemental notice. EPA
modified the DOT waiver provision in
several ways to address a few comments
about the problems that could be caused
if EPA changed the adopted DOT
requirements for pesticides that are DOT
hazardous materials. First, a separate
waiver/modification provision is
included for pesticides that are not DOT
hazardous materials and for pesticides
that are DOT hazardous materials.
Second, the waiver/modification
provision for pesticides that are DOT
hazardous materials specifies that EPA
will modify or waive the requirements
in § 165.25(b) only after consulting with
DOT to ensure consistency with DOT
regulations and exemptions. The final
rule also adds waiver/modification
provisions for the container dispensing
standards.
The waiver/modification provisions
are included to address situations where
the nonrefillable container requirements
might compromise the success, safety
and effectiveness of currently used
containers or those developed in the
future. While EPA has attempted to
focus each nonrefillable container
requirement on containers and
pesticides for which it is appropriate,
we are not familiar with every container
used for every product. It is likely that
there are some problematic situations
where existing containers that are
specifically designed for a certain use or
adaptation may have difficulty
complying with the final regulations.
We may not be aware of these situations
and they may not have been mentioned
by commenters. In general, waivers or
modifications are intended to provide
relief for a limited number of situations,
and we wanted to provide a mechanism
to account for these situations without
having to amend the regulations.
Waivers and modifications are
appropriate in a limited number of
situations, such as the use of nonstandard closures, since the point of the
requirement is to limit the number of
closures (and therefore adapters) to
encourage the use of closed transfer
systems.
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J. Procedure for Applying for a Waiver
or Modification (§ 165.25(h))
1. Final regulations. Section 165.25(h)
describes the procedure for registrants
to follow if they want to obtain a waiver
from or a modification to any of the
nonrefillable container standards. The
regulations specify that a registrant
cannot distribute or sell a pesticide
product in a nonrefillable container that
does not comply with all of the
nonrefillable container standards unless
and until EPA approves the request for
the waiver or modification in writing.
To obtain a waiver or modification, a
registrant must submit a written request
for a waiver or a modification to the
EPA’s Office of Pesticide Programs at
the address provided in the regulations.
Two copies of the following information
(which may be part of an application for
registration or amended registration)
must be included with the request:
• The name and address of the
registrant; the date; and the name, title,
signature, and phone number of the
company official making the request.
• The name and EPA registration
number of the relevant pesticide
product.
• A statement specifying the
requirement(s) from which the waiver or
a modification is requested.
• A description of the relevant
nonrefillable container(s).
• Documentation or justification to
demonstrate that the applicable waiver
or modification criteria in § 165.25(g)
are satisfied.
2. Changes. The procedure for
obtaining all waivers and modifications
is essentially the same as the procedure
proposed (in § 165.119) for obtaining a
waiver of the standard closure
requirement. No specific procedure was
identified for the residue removal
waiver in the proposed rule or for the
waiver from DOT requirements in the
1999 supplemental notice.
Consolidating all of the waiver criteria
in § 165.25(g) and using the same
procedure for all waivers requests
should facilitate the process for
registrants and EPA. Therefore, the
significant change to the waiver
procedure requirements in the final rule
is that they clearly apply to all waiver
requests. Several additional minor
modifications were made to the final
rule, including updating the address,
clarifying the statement requiring EPA
approval before a pesticide product can
be sold or distributed in containers with
waived or modified requirements,
broadening several of the information
items to accommodate the additional
waiver provisions, and clarifying that a
waiver request could apply to more than
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one nonrefillable container design for
the identified pesticide product.
Because the waiver and modification
requests are part of an application for
registration or amended registration,
each waiver request must apply to only
one product.
K. Reporting (§ 165.27(a))
1. Final regulations. This section
clarifies that the pesticide container
regulations do not require registrants to
report to EPA with information about
their nonrefillable containers. It refers
registrants to the reporting standards in
40 CFR part 159 to determine if
information on container failures or
other incidents involving pesticide
containers must be reported to EPA
under FIFRA section 6(a)(2).
2. Changes. The intent and substance
of this standard is the same as in the
proposal. However, the wording was
changed to clarify that this is simply a
reference to the existing 6(a)(2)
standards and that it does not add any
new requirements.
L. Recordkeeping (§ 165.27(b))
1. Final regulations. For each product
that is subject to the full set of
nonrefillable container regulations and
is distributed and sold in nonrefillable
containers, registrants must keep the
following records for as long as a
nonrefillable container is used for the
product and for 3 years thereafter:
• The name and EPA registration
number of the product.
• A description of the container(s)
used to distribute or sell the product.
• Documentation of compliance with
the closure requirement, if applicable.
• Documentation of compliance with
the dispensing requirement, if
applicable.
• Documentation of compliance with
the residue removal requirement, if
applicable.
The registrant must make these
records available for inspection or
copying upon request by an employee of
EPA or any entity designated by EPA,
such as a State, another political
subdivision or a Tribe.
2. Changes. The requirements are
substantially the same as proposed.
Several minor modifications were made
in the final rule to improve the clarity
of the recordkeeping requirements,
including:
• Deleting ‘‘design type’’ in several
places to clarify that the requirements
apply to the containers used to
distribute or sell the product. However,
the specific records for the dispensing
and residue removal recordkeeping
allow information for different
containers and products to be used to
document compliance, under the
specified conditions.
• The first sentence in the
recordkeeping requirement in the final
rule was revised to clarify that the
recordkeeping applies to pesticide
products distributed or sold in
nonrefillable containers and that are
subject to the full set of nonrefillable
container regulations in §§ 165.25 165.27. In other words, products that are
completely exempt and products that
must comply only with the standards in
49 CFR 173.24 do not have any
recordkeeping requirements. This
change was necessary because of the
changes in the scope of products that
47367
are subject to the nonrefillable container
standards.
• Because the requirement for
registrants to submit a certification is
not being finalized, the need to keep a
record of the certification is no longer
necessary.
• For the closure-related records,
several minor changes were made to
further describe the kinds of
documentation that would be
acceptable.
M. Proposed Standards That Are Not
Being Finalized
1. Final regulation/changes. The
following requirements relating to
container design from the proposed
regulation are not being finalized in the
final rule:
• § 165.102(b): Container integrity
and compatibility;
• § 165.102(c)(1): Permanently
marking the EPA registration number;
• § 165.102(c)(2): Permanently
marking the container’s material of
construction;
• § 165.102(d)(3): Requiring the
container to reclose securely; and
• § 165.106: Residue removal
methodology for dilutable products in
rigid containers
• § 165.111: Certification.
Three of these proposed requirements
for nonrefillable containers are not
being finalized because they were
replaced by equivalent DOT
requirements. The following table lists
the non-finalized requirements from the
proposed rule and the DOT equivalent
regulations:
TABLE 13.—PROPOSED NONREFILLABLE CONTAINER STANDARDS THAT WERE NOT FINALIZED AND THEIR DOT
EQUIVALENTS
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Proposed Pesticide Container Requirement
Proposed 40 CFR Cite
Equivalent 49 CFR Cite
Container integrity and compatibility
§ 165.102(b)
§§ 173.24(b), 173.24(e)
Permanently marking the material of
construction
§ 165.102(c)(2)
§§ 178.3(a), 178.503(a)
Requiring the container to reclose securely
§ 165.102(d)(3)
§ 173.24(f)
As discussed in Units V.H.1. and
V.H.4., the residue removal testing
methodology that was proposed in
§ 165.106 is not being finalized in the
regulatory language and will be
incorporated into EPA’s testing
guidelines. The test procedure is
established as an OPP test procedure
titled ‘‘Rinsing Procedures for Dilutable
Pesticide Products in Rigid Containers.’’
(Ref. 20) The proposed regulatory
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language provided some details of the
test procedure, which EPA intended to
supplement with guidance. The final
rule does not include the specific testing
requirements because we believe it is
more appropriate to provide these
details in a test protocol than in the
regulations.
EPA decided not to finalize the
proposed requirement in § 165.102(c)(1)
that each nonrefillable container be
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permanently marked with the EPA
registration number of the pesticide in
the final rule. Also, EPA is not finalizing
the proposed requirement in § 165.111
for registrants to certify that their
nonrefillable containers meet the
standards and to submit the
certifications to EPA.
2. Comments - EPA registration
number. Several State regulatory
agencies supported requiring the EPA
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registration number, saying it would
help in the identification and disposal
of unwanted and/or abandoned
pesticides. One acknowledged that the
container might not hold its original
contents, but that the benefits outweigh
the disadvantages. One commenter
suggested imbedding identification
stripes in bags to identify the contents
and another recommended requiring the
year the pesticide was manufactured in
addition to the EPA registration number.
Almost 30 commenters, including
almost 20 registrants, some registrant
groups, a few container manufacturer
groups, and a State regulatory agency,
opposed requiring the EPA registration
number to be permanently marked on
the container because the container may
not hold its original contents, the
number is already on the pesticide label,
it would be too expensive, and it would
create inventory and container ordering
problems.
3. EPA response - EPA Registration
Number. This requirement was intended
to help the managers of State pesticide
collection and disposal programs (often
called Clean Sweep programs) identify
unknown pesticides when they receive
containers without labels. However,
based on the comments, we no longer
believe that the benefits of this standard
would outweigh the costs. EPA believes
that many commenters misunderstood
the intent of the proposed interpretation
of permanent marking because the
comments implied that the EPA
registration number would have to be
embossed in the container. This was not
the intent of the proposal, which would
have allowed ink jetting, so the
comments regarding inventory problems
and some of the costs are not relevant.
However, even the estimates for ink jet
printing and the costs to alter a filling
line are substantial when extrapolated
to all of the formulators, particularly
when the actual benefits are unclear.
EPA doesn’t question the benefit of
helping State pesticide disposal
programs identify pesticides to facilitate
and minimize the cost of disposing of
unwanted pesticides. However, there
are many legitimate questions about
how often this might happen and how
much confidence a pesticide disposal
program manager would have that the
container holds its original contents.
(See the discussion of good stewardship
for service containers in Unit VII.L. of
this preamble.) Also, the EPA
registration number is required on the
pesticide’s label. Therefore, EPA is not
finalizing this requirement in today’s
final nonrefillable container regulations.
EPA continues to believe that durably
marking a product’s EPA registration
number on its nonrefillable containers is
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a good practice and we encourage
registrants to do this (or continue doing
it), although it is not required.
4. Comments - certification. A
registrant group commented that
registrants would be able to certify
compliance if appropriate standards are
established. Another registrant group
commented that current registration
guidelines make the certification
redundant and claimed that the
requirement to certify was not in
compliance with the Paperwork
Reduction Act. A registrant group and a
registrant urged EPA to develop
guidance to define what registrants
should certify, because it is unclear
what must be certified and when. A
registrant group and a registrant/
distributor said that formulators and
subregistrants should be allowed to
meet this requirement by a data
certification process.
5. EPA response - certification. EPA
considered modifying the certification
requirement to clarify the intent.
However, EPA decided not to finalize
the certification requirement because, in
this case, we believe that the benefits of
having registrants certify compliance are
outweighed by the paperwork burden
on industry and EPA. EPA believes that
having a high level official certify
compliance with the regulations
generally facilitates compliance by
having companies focus on the
regulations up-front and by creating an
incentive for that official to ensure
compliance because of the
responsibility of signing such a
statement. However, the registrants will
already be sending in a submission with
an official’s signature because of the
changes to the pesticide storage and
disposal label statements. Therefore, we
believe that some of the benefits of the
label submissions will carry over onto
the container standards. Also, this
approach should eliminate potential
confusion about submitting label
changes and certifications if a product
must comply with the label changes in
this rule but not the nonrefillable
container standards (because of different
scopes). Lastly, the container
regulations, promulgated under the
authority of FIFRA section 19, are
directly enforceable by section
12(a)(2)(S) of FIFRA, which states that it
is unlawful to violate any regulation
issued under section 3(a) or 19. In other
words, the certifications are not
necessary to enforce these regulations.
For all of these reasons, EPA decided
not to finalize the certification
requirement in today’s final rule.
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VI. Refillable Containers
A. Key Terms
1. Overview. The following terms,
defined in § 165.3 of subpart A, are key
to understanding the refillable container
standards in subpart C.
(1) Dry pesticide
(2) One-way valve
(3) Portable pesticide container
(4) Refillable container
(5) Stationary pesticide container
(6) Tamper-evident device
(7) Transport vehicle.
Three of these definitions--dry
pesticide, tamper-evident device, and
transport vehicle--are identical to the
proposed definitions. The definition of
refillable container was slightly
modified to clarify that refillable
containers are used for sale or
distribution. As discussed below, a
definition of portable pesticide
container has been added to the final
rule and the other two definitions were
changed substantively.
The following proposed definitions
that were relevant to the proposed
refillable container standards are not
being finalized: dry bulk container; dry
minibulk container; liquid bulk
container; and liquid minibulk
container. These are discussed below in
conjunction with stationary pesticide
container.
2. One-way valve—i. Final regulation.
One-way valve means a valve that is
designed and constructed to allow
virtually unrestricted flow in one
direction and no flow in the opposition
direction, thus allowing the withdrawal
of material from, but not the
introduction of material into a
container.
ii. Changes. EPA incorporated the
following phrase, as suggested by a
registrant: ‘‘to allow virtually
unrestricted flow in one direction and
no flow in the opposition direction.’’
EPA believes this improves the
definition by clarifying what we mean
by one-way.
3. Stationary pesticide container—i.
Final regulation. Stationary pesticide
container means a refillable container
that is fixed at a single facility or
establishment or, if not fixed, remains at
the facility or establishment for at least
30 consecutive days, and that holds
pesticide during the entire time.
ii. Changes. The proposed definition
for ‘‘stationary bulk container’’ was
revised in several ways, as discussed in
detail in Unit VIII.E. of this preamble,
which describes the containers that are
subject to the containment
requirements. The final rule changes the
term from ‘‘stationary bulk container’’ to
‘‘stationary pesticide container’’ because
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the changes to the final containment
regulations eliminated the need for the
proposed definitions of minibulk and
bulk containers.
The proposed containment
regulations would have required each
stationary bulk container to be protected
by a secondary containment unit. The
proposed rule defined stationary bulk
container to be ‘‘a liquid bulk container
or a dry bulk container that is fixed at
a single facility or establishment...’’ The
proposed rule also defined liquid bulk
and dry bulk containers by size. For
example, liquid bulk container was
defined as ‘‘a refillable container
designed and constructed to hold liquid
pesticide formulations with the capacity
to hold undivided quantities of greater
than 3,000 liters (793 gallons).’’
The final containment regulations
take a different approach of delineating
the containers that must be within
secondary containment units. Section
165.81(b) states that ‘‘Stationary
pesticide containers designed to hold
undivided quantities of agricultural
pesticides equal to or greater than 500
gallons (1,890 liters) of liquid pesticide
or equal to or greater than 4,000 pounds
(1,818 kilograms) of dry pesticide are
subject to the regulations in this subpart
and must have a secondary containment
unit that complies with the provisions
of this subpart ...’’ Because the container
sizes are a regulatory criterion in
§ 165.81(b), the definitions of liquid
bulk container and dry bulk container
are no longer necessary and are not
being finalized. The definition of dry
minibulk container was not used in the
proposed or final regulations and is also
not being finalized.
4. Portable pesticide container—i.
Final regulation. Portable pesticide
container means a refillable container
that is not a stationary pesticide
container.
ii. Changes. The proposed regulations
did not define portable pesticide
container. However, this definition is
necessary in the final rule to replace the
term liquid minibulk container in the
refillable container regulations. As
described above, EPA is not finalizing
the definitions for liquid bulk, dry bulk
and dry minibulk containers because
they are not necessary. Similarly, EPA
believes that it is logical to not finalize
the definition for liquid minibulk
container. In the proposal, the only time
the term liquid minibulk container was
used in the regulatory language was to
define the kinds of refillable containers
that had to comply with the one-way
valve/tamper-evident device
requirement. In the final rule, EPA
partially describes the containers that
must comply with the one-way valve/
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tamper-evident requirement in
§ 165.45(e) as ‘‘a refillable container that
is a portable pesticide container that is
designed to hold liquid pesticide
formulations...’’
B. Purpose (§ 165.40(a))
1. Final regulations. The purpose of
the refillable container standards is to
establish design and construction
requirements for refillable containers
used for the distribution or sale of some
pesticide products.
2. Changes. This is nearly the same as
the proposed purpose (in § 165.120(a)).
One minor change was to acknowledge
the reduced number of products that are
subject to the final regulations by stating
that the rule applies only to the
distribution or sale of some pesticide
products. The proposed regulations
would have applied to all products.
Another insignificant modification was
to delete the term ‘‘standards’’ from the
phrase ‘‘establish standards and
requirements’’ because it is redundant.
C. Who Must Comply (§ 165.40(b))?
1. Final regulations. You must comply
with all of the refillable container
regulations if you are a registrant who
distributes or sells a pesticide product
in refillable containers. If your product
is subject to the refillable container
regulations as described in Unit VI.E.,
the product must be distributed or sold
in refillable containers that comply with
these regulations. This is true regardless
of whether you repackage the product
into the container yourself or whether
you sell or distribute the product to an
independent refiller, who repackages
your product into refillable containers.
In addition, you must comply with
the regulations in § 165.45(f) for
stationary pesticide containers if you are
a refiller of a pesticide product and you
are not the registrant of the pesticide
product.
2. Changes. For registrants, this is the
same approach that we proposed in
§§ 165.122(a)(1)(i) and 165.122(a)(2)(i).
However, the wording is more
straightforward because the regulations
for refillable containers were separated
from the repackaging regulations in the
final rule. This subpart includes only
the refillable container standards, which
apply to all registrants that use refillable
containers to distribute or sell their
products. The standards for repackaging
were placed in a separate subpart,
because those regulations must
distinguish between registrants who
repackage product directly into the
containers and registrants who allow
independent refillers to repackage their
product into refillable containers.
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The final rule clarifies that refillers
must comply with the requirements for
stationary pesticide containers in
§ 165.45(f). EPA believes it is reasonable
to hold both the registrants and refillers
responsible for meeting the stationary
pesticide container standards in
§ 165.45(f) because they are both selling
and distributing the pesticide that is
held in those containers.
D. Compliance Dates (§ 165.40(c))
1. Final regulations. The final
regulations provide a 5–year period after
the date of publication of the final rule
in the Federal Register before
compliance with the refillable container
standards is required. Specifically,
within 5 years from today’s date,
registrants must distribute or sell all
pesticide products in refillable
containers in compliance with these
regulations.
2. Changes. Based on the comments,
EPA decided to extend the compliance
period from the 2–year time frame that
was proposed in § 165.139. Also, the
compliance date for registrants to
submit certifications is not being
finalized because the certification
requirement from the proposal is not
being finalized, as described in Unit
VI.M.
3. Comments. A few commenters
(registrant groups, a registrant and a
State) on the proposed rule supported a
2–year compliance period if EPA adopts
a grandfather clause or references the
DOT regulations rather than the
proposed regulations. However, many
commenters (mostly registrants, but also
a dealer group and a few States) argued
for a longer compliance period to allow
the continued use of sound containers
and to minimize the burden of
retrofitting containers or replacing the
containers in inventory. Because
refillable containers can be used for
many years (the average life span is 5
years for plastic minibulks and 15 years
for steel minibulks), a 2–year phase-in
period would require companies to
dispose of good containers or to retrofit
them. Several of the commenters
mentioned that it would take longer
than 2 years to come into compliance.
In addition, many commenters
(registrants and registrant groups) on the
supplemental notice stressed the need
for an adequate transition period
regarding the option of adopting the
DOT Packing Group III standards in the
final rule. The main points made by the
commenters included:
• An adequate transition period is
required to design and obtain new
packaging, finish using existing supplies
of previously authorized packaging,
allow existing nonrefillable packaging to
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work its way through the distribution
system and let refillable packaging
complete its useful life.
• An inadequate transition period
would significantly increase the cost of
compliance with this rule. Major costs
would be avoided as long as it is not
necessary to dispose of packaging which
has not yet reached the end of its useful
life or to recall packaging which is still
in the distribution channels and has not
yet reached its final destination. The
suggested transition periods would
minimize the cost impact of the EPA
container regulation.
• Pesticide products change hands
several times as they move down the
distribution chain from the basic
producer to the end user (basic
producers, formulators, distributors,
retail dealers, brokers, custom
applicators and end users). In many
cases, the movement of materials is
reversed when products are not
consumed.
• The distribution process normally
is completed in a given sales year.
However, when materials are not
consumed, inventories build at all levels
of the distribution chain. Quite often
materials may be held in inventory for
multiple years before re-entering the
distribution network. During periods
when materials are being held in
inventory, the pesticide formulators and
others are negatively impacted when
regulatory changes are imposed on
products in the distribution chain
(rather than on products that will be
sold or distributed at some future date),
which involves substantial expenses to
producers with, in most cases, no
justifiable gain in safety.
4. EPA response. As described above,
EPA is extending the compliance period
for refillable containers to 5 years to
provide for a smoother and less
burdensome transition for companies.
Companies that have already made
significant investments in refillable
containers will be able to use their
existing containers for 5 years, which
covers the average expected lifetime of
a plastic minibulk container. Also, the
changes to the refillable container
standards will allow existing refillable
containers that meet the DOT Packing
Group III standards to be retrofitted
relatively easily (by durably marking
each container with a serial number and
having a one-way valve and/or tamperevident device on each opening of
liquid minibulk containers) so they can
continue being used. EPA believes that
the longer compliance period in the
final regulations is reasonable and
should apply equally to all products and
all refillable containers.
E. Pesticide Products Included
(§ 165.43(a) - (g))
1. Final regulations. As described in
detail in Unit III., only certain products
have to comply with the refillable
container standards. MUPs, plantincorporated protectants, and certain
antimicrobial products are completely
exempt from the refillable container
requirements. All other pesticide
products are subject to the refillable
container regulations.
Some of the antimicrobial pesticides
that are subject to the refillable
container regulations are subject to a
reduced set of regulations. In particular,
antimicrobial pesticides that are used in
swimming pools and closely related
sites (such as hot tubs, spas and
whirlpools) are exempt from the
requirements for marking the serial
number and having a one-way valve
and/or tamper-evident device on each
opening.
2. Changes. In the proposed rule, only
MUPs were exempt from the refillable
container regulations (in
§ 165.122(b)(1)). All other products
would have been subject to the
standards. The 1999 supplemental
notice discussed regulatory options for
exempting some products
(antimicrobials and non-antimicrobials)
from the full set of refillable container
regulations and for exempting certain
antimicrobial products from specific
requirements.
The criteria in the final rule for
exempting antimicrobials are different
than those discussed in the
supplemental notice and the final rule
exempts plant-incorporated protectants.
The final refillable container regulations
do not incorporate the toxicity category,
container size or environmental hazard
criteria from the supplemental notice.
Also, the final rule changes some
aspects of the supplemental notice
approach of subjecting antimicrobial
swimming pool products to a reduced
set of requirements.
Table 14 describes the provisions for
determining which pesticide products
are subject to which refillable container
regulations and a brief explanation of
how (or if) this provision changed from
the proposal and/or the supplemental
notice.
TABLE 14.—CHANGES TO THE SCOPE OF THE REFILLABLE CONTAINER REGULATIONS
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Regulatory Provision
Changes
Manufacturing use products are exempt.
No change from proposed rule or supplemental notice.
Plant-incorporated protectants are exempt.
Plant-incorporated protectants would have been subject to the proposed
rule. The regulations for plant-incorporated protectants were finalized in
2001. We are exempting them from the final rule because of their
unique nature.
Certain antimicrobial products are exempt.
Antimicrobial products would have been subject to the proposed rule.
The final rule implements an approach similar to option 1 in the supplemental notice, although some of the details are different.
All other products are subject to the refillable container requirements, except for certain antimicrobial swimming pool products.
All products other than manufacturing products would have been subject
to the proposed rule. The final rule is different than the approach discussed in the supplemental notice, which would have exempted products in Toxicity Category III or IV in small containers and outdoor use
products without the specified environmental hazard statements on
their label.
Antimicrobial products used in swimming pools and closely related
sites are subject to a reduced set of refillable container requirements.
Antimicrobial products used in swimming pools would have been subject
to the proposed rule. The final rule is the result that was intended in
the supplemental notice, although the specifics of how it is implemented in the final rule are different than in the supplemental notice.
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F. Other Exemptions (§ 165.43(h))
Final regulations and changes. The
refillable container regulations do not
apply to transport vehicles that contain
pesticide in pesticide-holding tanks that
are an integral part of the transport
vehicle and that are the primary
containment for the pesticide. This is
identical to the exemption proposed in
§ 165.122(b)(2). In addition, the final
rule includes a specific exemption for
gaseous pesticides, which is necessary
to implement our intent from the
proposal because the final rule does not
use the proposed terms liquid minibulk,
dry minibulk, liquid bulk and dry bulk
containers, which would have excluded
gaseous pesticides.
G. DOT Standards (§ 165.45(a) - (c))
1. Final regulations. As discussed in
detail in Unit IV., refillable containers
must comply with the DOT Hazardous
Materials Regulations that are referred
to and adopted into EPA’s regulations.
These incorporated regulations establish
requirements for container design,
construction and marking.
2. Changes. This is a change from the
proposed regulation, although the
approach of referring to and adopting a
subset of the DOT standards was
discussed in detail in the 1999
supplemental notice. See Unit IV. for a
detailed discussion. As discussed in
Unit VI.M., some of the proposed
requirements for refillable containers
are not being finalized in the final rule
because they were replaced by
equivalent DOT requirements.
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H. Serial Number Marking (§ 165.45(d))
1. Final regulations. Each refillable
container must be marked in a durable
and clearly visible manner with a serial
number or other identifying code that
will distinguish the individual
container from all other containers.
Durable marking includes, but is not
limited to etching, embossing, ink
jetting, stamping, heat stamping,
mechanically attaching a plate, molding,
and marking with durable ink. The
serial number or other identifying code
must be located on the outside part of
the container except on a closure.
Placement on the label or labeling is not
sufficient unless the label is an integral,
permanent part of or permanently
stamped on the container. Antimicrobial
products used in swimming pools and
closely related sites (that are subject to
the regulations) are exempt from this
requirement.
2. Changes. The marking requirement
was changed significantly from the
proposal to the final rule. First, the
proposed rule included seven pieces of
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information that would have been
marked on the containers and the final
rule only includes one piece of data, the
serial number (or other identifying
code). Some of the proposed items--the
container manufacturer, date of
manufacture, rated capacity, and
material of construction--were deleted
because this information is required in
the DOT standards. The other pieces of
information--the model number and the
phrase ‘‘Meets EPA standards for
refillable containers’’--were deleted
from the regulations because they are no
longer necessary for implementing the
refillable container and repackaging
requirements due to the change to refer
to and adopt the DOT regulations and
because commenters raised some
legitimate problems with them.
Second, the regulatory text was
changed to clarify that the serial number
(or identifying code) must be durably
marked on the container, rather than
permanently marked as stated in the
proposed regulations. EPA’s intent for
permanent marking in the proposal was
described in the preamble as
‘‘Permanent marking includes, but is not
limited to, etching, embossing, ink
jetting, stamping, heat stamping,
mechanically attaching a plate, molding,
or marking with durable ink.’’ EPA
believes that durable marking is a more
accurate term to describe our intent. The
text in the final regulation-- ‘‘must be
marked in a durable and clearly visible
manner’’--is based on the DOT marking
standards for intermediate bulk
containers in 49 CFR 178.703(a)(1).
Third, the proposal included a
provision that allowed compliance with
a similar DOT marking requirement to
satisfy the corresponding EPA pesticide
container standard. This provision is no
longer necessary because the final
regulation refers to and adopts some of
the DOT standards.
3. Comments - permanent marking.
The proposal for the container marking
drew a large number of comments.
About 20 commenters, consisting
mainly of registrants, registrant groups,
and container manufacturer groups,
addressed EPA’s interpretation of
permanent marking. These comments
focused on the proposed permanent
marking requirements for nonrefillable
containers, but are applicable to the
refillable container and label regulations
as well. These comments are included
in the refillable container section
because the marking requirements for
nonrefillable containers are not being
finalized.
One registrant supported the list of
different techniques that would qualify
for permanent marking. Some
respondents (registrants and registrant
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groups) specifically supported including
ink jetting as a means of permanent
marking and one suggested adding
rubber-stamping to the list. A few
registrants commented that many inks
can be removed with solvent-based
products.
Some commenters (registrants and
registrant groups) urged EPA to move
the list of acceptable forms of
permanent marking from the preamble
to the regulations if permanent marking
is required. Respondents said this
would prevent confusion and
misunderstanding during enforcement.
One container manufacturer group
discussed the difference between the
UN/DOT terms ‘‘permanent’’ and
‘‘durable’’ and suggested that EPA’s
purposes would be met by requiring
durable marking. A registrant provided
similar comments and supported marks
that are ‘‘long-lasting and persistent
through the life of the pesticide.’’ This
registrant also commented that
permanent marking is best performed by
container manufacturers, although
registrants can add durable marking,
such as ink jetting and stenciling with
paint. A container manufacturer group
supported providing options because
different types of markings are suitable
for different container types, but
opposed mechanically attaching a plate
to plastic containers and expressed
concern about some of the other
alternatives.
Some respondents (registrants and
registrant groups) urged EPA to allow
the use of pressure-sensitive labels and/
or labels attached with permanent
adhesive as alternative ways to comply
with the permanent marking
requirement. A container manufacturer
group recommended requiring the
containers to be marked in a manner
‘‘that at least some of the material from
which the container is made must be
destroyed to remove the marking.’’ A
pesticide user commented that the
marking should be legible after the third
water rinse and dry cycles.
4. EPA response - permanent marking.
EPA modified the approach toward
permanent marking several ways in the
final rule to eliminate confusion about
the intent and to facilitate compliance.
First, EPA changed the description of
marking from ‘‘permanent’’ to ‘‘durable’’
marking. EPA believes that durable
marking is a more accurate term to
describe our intent because the
description of ‘‘permanent’’ marking in
the preamble of the proposal included
marking methods, such as ink jetting,
stamping and marking with durable ink,
that are durable but not permanent.
Second, the final rule clarifies that ink
jetting and stamping are allowable
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methods of marking the required
information on the containers. Third,
the allowable methods of marking are
listed in the regulations, rather than
only in the preamble or guidance
material, to enhance the understanding
of the intent.
5. Comments - serial numbers. Serial
numbers were uniformly opposed by
several registrants, several registrant
groups, and a container manufacturer
because these commenters claimed
requiring serial numbers would greatly
increase the cost of compliance. Several
commenters focused on the potential
impact on plastic and steel drums and
flexible intermediate bulk containers,
and said it would be very burdensome
to permanently mark a serial number on
each container. Three respondents
specifically addressed swimming pool
chemicals. These commenters stated
that the requirement for serial numbers
and the associated recordkeeping
requirements would be completely
unworkable for refillable pool chemicals
because millions of refillable containers
(from 1 to 55 gallons) are used each year
and a single shipment can contain 4,000
to 5,000 bottles. This increased cost
would make refillable containers
uneconomical for swimming pool
chemicals, which would lead to the
registrants switching to nonrefillable
plastic jugs.
6. EPA response - serial numbers. EPA
disagrees with commenters that the cost
of complying with the serial number
requirement (for products other than
swimming pool chemicals) would be
overly burdensome. First, the final
regulation clarifies that the serial
number must only be durably marked,
not permanently marked. Therefore, it
would not have to be done by an
automatic marking device capable of
changing each time a new container is
made. Second, this standard only
applies to containers that are refilled. It
does not apply to containers that are
being reconditioned, remanufactured or
repaired according to the DOT standards
in 49 CFR 173.28 or 180.352. In other
words, it does not apply to drums that
are used once and reconditioned
according to DOT standards and then
filled with pesticide or another
substance. See the discussion in Unit
IV.B. that states that the reference to 49
CFR 173.28 is included in the final
regulations to allow drums to be
reconditioned and then reused under
the pesticide container regulations.
EPA agrees with the commenters that
applying serial numbers (and some
other requirements) to refillable
containers used for swimming pool
pesticides would disrupt the current
refillable container system for
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swimming pool chemicals and would
quite likely cause the refillables to be
replaced by millions of single-use,
nonrefillable containers. Therefore, the
final rule exempts antimicrobial
products used in swimming pools and
closely related sites (and that are subject
to the regulations) from the serial
number requirement.
I. Openings - One-Way Valves or
Tamper-Evident Devices (§ 165.45(e))
1. Final regulations. Like the
proposed rule, this standard applies
only to portable pesticide (refillable)
containers designed to hold liquids--not
portable pesticide containers for dry
pesticides or stationary pesticide
containers. Also, this standard does not
apply to cylinders that comply with the
DOT HMR. Each opening of a portable
pesticide container for liquid materials
(except for DOT cylinders) other than a
vent must have a one-way valve, a
tamper-evident device or both. A oneway valve may be located in a device or
system separate from the container if the
device or system is the only reasonably
foreseeable way to withdraw pesticide
from the container. A vent must be
designed to minimize the amount of
material that could be introduced into
the container through it.
2. Changes. EPA made several
modifications to this requirement. First,
the description of the containers that
must comply was changed to portable
pesticide containers that are designed to
hold liquid formulations because the
definition of liquid minibulk container
is not being finalized. Second, we
changed the word ‘‘aperture’’ in the
proposal to ‘‘opening’’ in the final rule
because it is a more common term that
should facilitate understanding and
therefore compliance with the
regulations. Third, the standard was
changed so vents do not need to have
tamper-evident devices or one-way
valves. Instead, a sentence was added to
ensure that vents are designed to
minimize the amount of material that
could be introduced into containers
through them. Fourth, the requirement
was amended to clarify that a one-way
valve may be located in a separate
device or system, such as a coupler, if
that device or system is the only
reasonably foreseeable way to withdraw
pesticide from the container. This was
the intent of the proposed standard, as
described in the 1994 preamble, but we
are adding it to the regulations for
clarity. Fifth, the final rule was
amended to state that this requirement
does not apply to cylinders that comply
with DOT’s Hazardous Materials
Regulations. Sixth, antimicrobial
products used in swimming pools and
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closely related sites (that are subject to
the regulations) are exempt from this
requirement.
3. Comments - vents. A container
manufacturer group pointed out that
vents are needed to provide air flow and
that a person could introduce a material
through a vent if they tried hard enough.
This commenter recommended
requiring vents to be designed to
minimize the introduction of material
through them. Similarly, a State
regulatory agency urged EPA to modify
the requirement to acknowledge that
vents are required on refillables and are
not one-way.
4. EPA response - vents. EPA agrees
with the commenters that vents are
needed to provide air flow when
unloading material from a container and
that vents do not meet the definitions of
either one-way valves or tamper-evident
devices. Therefore, EPA modified the
regulations to clarify that vents do not
need one-way valves or tamper-evident
devices, but that they must be designed
to minimize the introduction of material
through them.
5. Comments - chloropicrin. A group
of chloropicrin manufacturers and users
cited several reasons why that product
should be exempt from the opening
requirement. This commenter provided
the following information:
• Chloropicrin is a highly volatile
liquid that is shipped and handled
essentially like a gas.
• End-use formulations containing
chloropicrin are shipped in refillable
steel containers manufactured under the
same DOT specifications as propane
cylinders.
• Chloropicrin containers typically
have only one specialized valve for
filling and emptying the cylinder and
specialized connections are required to
fill them.
• Chloropicrin cylinders contain
screw-on valve protections known as
bonnets. The commenter stated that
adding external one-way valves is not
possible due to space limitations and
increasing the size of the bonnets would
reduce the ability of the bonnet to
protect the valve.
In addition, the commenter claimed
that:
• The specialized valve and refilling
connections minimize the chance of
contamination or unauthorized filling.
• No valves were available in 1994
that were compatible with chloropicrin
and that allow filling and emptying the
container through a one-way valve.
• Installing one-way valves on
thousands of existing cylinders could
cause unnecessary worker exposure.
6. EPA response - chloropicrin. EPA
agrees that the one-way valve/tamper-
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evident device requirement could be
problematic for cylinders, such as those
used to distribute chloropicrin end-use
products and propane. The one-way
valve/tamper-evident device
requirement applies to portable
pesticide containers for liquid materials,
which we envisioned as DOT portable
tanks, IBCs and the non-bulk refillable
containers designed to hold liquids. As
explained by the commenter,
chloropicrin is unusual in the sense that
it is a liquid, but it is shipped and
handled essentially like a gas. DOT
classifies chloropicrin as hazard
division 6.1 (poisonous material). EPA
believes that the DOT specifications for
cylinders are extremely detailed and
extensive and we do not want to add
requirements to them that would
compromise the safety and protection
provided by the DOT cylinder
requirements. Note that cylinders
holding gases would not be subject to
the one-way valve/tamper-evident
device requirement because they are
exempt from the refillable container
regulations by § 165.43(h)(2).
EPA believes that the chloropicrin
cylinders described by the commenter
should not have to comply with the oneway valve/tamper-evident device
requirement. However, rather than
specifically exempt containers holding
chloropicrin, the final regulations take a
more general approach and exclude
cylinders that comply with the DOT
HMR. The more general approach was
taken because there may be other highly
volatile liquid pesticides that are
distributed in DOT cylinders that would
face the same difficulties in complying
with this requirement.
7. Comments - sodium hypochlorite.
In comments on the proposed rule, a
registrant group stated that the one-way
valves identified in their research cost
several times more than the refillable
containers used to distribute sodium
hypochlorite. According to this
commenter, the one-way valve costs (in
1994) ranged from $10 for a 1–gallon
container to $45 for a 55–gallon
container. Another registrant group
identified one-way valves as one aspect
of the proposed regulations that would
make refillable containers economically
unfeasible for sodium hypochlorite in
the swimming pool industry. A trade
group representing all aspects of the
swimming pool industry explained that
sodium hypochlorite is a relatively low
value product that sold for as little as
$1.00 per gallon in 1994. At the time,
purchasers would pay a deposit of $0.50
to $1.00 per refillable container. This
commenter believes that the proposed
regulations would make the refillable
jugs used to distribute sodium
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hypochlorite for swimming pool use
prohibitively expensive. All of these
commenters favored exempting sodium
hypochlorite from the pesticide
container rule.
The comments on the supplemental
notice were similar. The trade group
representing all aspects of the
swimming pool industry stated that the
proposal to exempt eligible Toxicity
Category I antimicrobial products used
in swimming pools from most of the
refillable container standards is
laudable, but that it does not go far
enough. A pool supply company
commented that using one-way valves
and serial numbers on its returnable
bottles would increase the cost to the
point where it could no longer compete
in the marketplace. A sodium
hypochlorite manufacturer stated that
the relatively low value of the product
makes the use of one-way valves
unaffordable. This commenter stated
that one-way valves for drums cost
about $75 container, not including the
connectors/adaptors that the applicators
would need. This manufacturer
identified a one-way valve device that
could be added to the refillable jugs for
about $3 per container, which is more
reasonable, but noted that these devices
could not be produced in large enough
quantities to account for all refillable
jugs currently in use.
8. EPA response - sodium
hypochlorite. EPA modified the
regulation to exempt antimicrobial
products (that are subject to the
regulations) used in swimming pools
and closely related sites from this
requirement for one-way valves or
tamper-evident devices. As stated in the
supplemental notice, EPA acknowledges
that applying some of the refillable
container standards, including this one,
to sodium hypochlorite used in
swimming pools would disrupt the
current refillable container system for
these products. This disruption would
probably cause the refillables to be
replaced by millions of single-use,
nonrefillable containers, which is
inconsistent with the goals of pollution
prevention and of facilitating the safe
refill and reuse of containers (FIFRA
section 19(e)). Therefore, the 1999
supplemental notice described a
regulatory option intended to exempt
swimming pool chemicals from some of
the refillable container requirements.
Based on comments and further
analysis, EPA realized that the products
for which relief was intended (sodium
hypochlorite) may be hazardous wastes
when disposed and, therefore, would
not be eligible for exemption as
described in the supplemental notice.
Therefore, the final rule was revised to
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clarify that swimming pool products are
exempt from the problematic
requirements. Currently, EPA is aware
of sodium hypochlorite products that fit
the exemption criteria and that are
distributed and sold in refillable
containers, although the partial
exemption was drafted to be general so
it would apply to any products that fit
the criteria. See Unit III.D. for a more
detailed discussion.
J. Stationary Pesticide Container
Standards (§ 165.45(f))
1. Final regulation. Stationary
pesticide containers that are designed to
hold undivided quantities of pesticides
equal to or greater than 500 gallons
(1,890 liters) of liquid pesticide or equal
to or greater than 4,000 pounds (1,818
kilograms) of dry pesticide and are
located at the refilling establishment of
a refiller operating under written
contract to a registrant must meet
certain standards. As discussed in Unit
VI.C., both registrants and refillers are
responsible for ensuring that these
requirements for stationary pesticide
containers are met. First, all of these
stationary pesticide containers (for
liquid and dry pesticides) must be:
• Resistant to extreme changes in
temperature,
• Constructed of materials that are
adequately thick and that are resistant to
corrosion, puncture, or cracking, and
• Capable of withstanding all
operating stresses.
As proposed, these requirements do
not apply during a civil emergency or
any unanticipated grave natural disaster
or other natural phenomenon of an
exceptional, inevitable and irresistible
character, the effects of which could not
have been prevented or avoided by the
exercise of due care or foresight.
Second, several other standards apply
only to liquid bulk containers.
Specifically,
• They must be equipped with a vent
or other device designed to relieve
excess pressure, prevent losses by
evaporation, and exclude precipitation.
• External sight gauges are
prohibited.
• Each container connection below
the normal liquid level must be
equipped with a shutoff valve, which is
capable of being locked closed.
• Shutoff valves must be located
within a secondary containment unit (if
secondary containment is required).
2. Changes. There were several
changes in this section from the
proposed rule. First, the description of
containers that must comply with these
requirements was changed to be
consistent with the quantities for
secondary containment structures
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because the definitions of liquid and dry
bulk containers are not being finalized.
Second, the requirement for shutoff
valves on liquid bulk containers was
amended to specify that a shutoff valve:
(1) Is only required for container
connections that are below the normal
liquid level; and (2) must be located
within a secondary containment unit, if
secondary containment is required by
subpart E. Third, the text for the shutoff
valve requirement was adjusted to make
it clear that the valves must be capable
of being locked closed. Fourth, the
proposed phrase ‘‘act of God’’ is not
included in the final rule. The language
in § 165.45(f)--‘‘any unanticipated grave
natural disaster or other natural
phenomenon of an exceptional,
inevitable and irresistible character, the
effects of which could not have been
prevented or avoided by the exercise of
due care or foresight’’--sufficiently
describes the kinds of events that would
be considered ‘‘acts of God,’’ so that
phrase is not necessary.
3. Comments - shutoff valve. Some
commenters addressed the need for
requiring shutoff valves and there were
few common themes among the
respondents. A few registrants and a
registrant group supported having all
connections on stationary liquid
pesticide containers (except for vents)
equipped with a lockable valve. A
container manufacturer group asked to
change the language to: ‘‘Each liquid
bulk container connection below the
normal liquid level...,’’ stating that
requiring valves above that level serves
no purpose on bulk tanks.
4. EPA response - shutoff valve. EPA
agrees with the container manufacturer
group and will amend the final rule so
the shutoff valve requirement applies to
liquid pesticide container connections
below the normal liquid level. Vents
and other openings on the top of the
container are above the normal liquid
level, so the phrase ‘‘except for vents’’
is no longer necessary and is not in the
final regulation.
5. Comments - location of shutoff
valve. EPA requested comments on
whether it is necessary to regulate the
location of shutoff valves, and if so,
what the location should be. Some
commenters (registrants, registrant
groups, dealer groups, and a State
regulatory agency) supported a general
guideline that would allow placement of
the valve anywhere within the
secondary containment. These
commenters believed that fine-tuning
the valve location wouldn’t increase
overall release protection as long as the
valve was in secondary containment.
Only one commenter, a State regulatory
agency, stated a preference for locating
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the valve close to the storage vessel,
saying that field experience has
demonstrated that valves are subject to
incidental spillage due to factors such as
‘‘pipe chatter.’’
6. EPA response - location of shutoff
valve. EPA agrees with the majority of
the commenters that shutoff valves
should be located within a secondary
containment unit. Therefore, this part of
the standard will be amended to specify
that the shutoff valve be located within
a secondary containment unit, if
secondary containment is required by
subpart E. EPA believes that nearly all,
if not all, stationary pesticide containers
that are subject to § 165.45(f) will be
required to be within a secondary
containment unit by subpart E.
However, subpart E applies only to
agricultural pesticides, so it is possible
that a container holding a
nonagricultural pesticide could be
subject to the stationary pesticide
container standards, but not the
containment standards.
K. Waivers and Modifications
(§ 165.45(g) - (h))
1. Final regulation. Section 165.45(g)
of the final rule explains that registrants
may request waivers from or
modifications to some of the refillable
container regulations and sets out the
criteria that must be met for EPA to
approve a waiver/modification request.
Section 165.45(g) regulations are
identical to the corresponding portion of
the waiver/modification provisions
regarding the DOT provisions for
nonrefillable containers in § 165.25(g).
Section 165.45(h) describes the
procedure for registrants to follow if
they want to obtain a waiver from or
modification to the specified refillable
container regulations. The procedure in
§ 165.45(h) is identical to the procedure
for obtaining waivers from or
modifications to the nonrefillable
container regulations in § 165.25(h).
2. Changes, comments and EPA
responses. The proposed rule did not
include any waiver or modification
provisions for the refillable container
regulations. The supplemental notice
discussed an approach for incorporating
a waiver from or modification to the
referenced and adopted DOT
requirements. EPA made several
changes to the supplemental approach
before incorporating the waiver/
modification provisions into the final
regulations. See Unit V.I. (on
nonrefillable containers) for changes,
comments and EPA responses regarding
the waivers from and modifications to
the pesticide container regulations that
refer to and adopt the DOT
requirements, which apply to both
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nonrefillable and refillable containers.
Unit V.J. provides more details on the
process for applying for waivers and
modifications, which is the same for
nonrefillable and refillable containers.
L. Reporting (§ 165.47)
1. Final regulation. This section
clarifies that the pesticide container
regulations do not require registrants to
report to EPA with information about
their refillable containers. However, it
refers registrants to the reporting
standards in 40 CFR part 159 to
determine if information on container
failures or other incidents involving
pesticide containers must be reported to
EPA under FIFRA section 6(a)(2).
2. Changes. The intent and substance
of this standard is the same as in the
proposal. However, the wording was
changed to clarify that this is simply a
reference to the existing 6(a)(2)
standards and that it does not add any
new requirements.
M. Proposed Standards That Are Not
Being Finalized
Final regulation/changes. The
following requirements relating to
refillable container design from the
proposed regulation are not being
finalized in today’s final rule:
• § 165.124(b)(1)(i) - (v) and (vii):
Permanent marking other than serial
numbers
• § 165.124(b)(2): Compliance with
DOT’s marking satisfies the
corresponding EPA permanent marking
requirement
• § 165.124(c): General minibulk
integrity standard
• § 165.124(d): Drop test for minibulk
containers (requirement)
• § 165.125: Minibulk container drop
test methodology (test procedure)
• § 165.128(a) & (b): Keep records of
container descriptions, minibulk drop
test results and the GLP statement
specified for the drop test.
• § 165.126: Certification
• § 165.128(c): Keep records of the
certification.
The first six proposed standards are
not being finalized in the refillable
container regulations because the
approach of referring to and adopting a
subset of the DOT standards makes
them unnecessary. In particular:
• Some of the items for permanent
marking in proposed § 165.124(b)(1)-the container manufacturer, date of
manufacture, rated capacity, and
material of construction--are not being
finalized because this information is
required in the DOT standards that
specify marking. Two other proposed
pieces of information--the model
number and the phrase ‘‘Meets EPA
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standards for refillable containers’’--are
not being finalized because they are no
longer necessary due to the change to
refer to and adopt the DOT regulations.
See Unit VI.H. for more detail about the
proposed marking requirements.
• The statement proposed in
§ 165.124(b)(2) is not being finalized
because the final rule specifically refers
to the DOT marking, so it is no longer
necessary to include a provision stating
that compliance with DOT’s marking
satisfies the corresponding EPA marking
requirement.
• The proposed general minibulk
integrity standard in § 165.124(c) is not
being finalized because the DOT
regulations address container integrity
in 49 CFR 173.24.
• The proposed drop test requirement
for minibulks in § 165.124(d) and the
proposed minibulk container drop test
in § 165.125 are not being finalized
because the DOT regulations include a
drop test requirement. The drop test
procedure for nonbulk packagings is
defined in 49 CFR 178.603 and the drop
test procedure for intermediate bulk
containers is defined in 49 CFR 178.810.
• The proposed recordkeeping
requirements in § 165.128(a) and (b) for
container descriptions, drop test results
and a GLP statement for the drop test
are not being finalized because they are
no longer necessary because compliance
with the DOT requirements can be
ensured by the structure and
certification standards in the DOT HMR.
Because we can rely on the DOT or UN
marking to ensure compliance with the
applicable DOT requirements, EPA no
longer needs to see records of the testing
to confirm compliance with the drop
test (and in the final rule) and other test
requirements.
The final two proposed items listed
above--having registrants certify
compliance with the regulations and the
associated recordkeeping--are not being
finalized for the same reasons that the
nonrefillable container certification and
recordkeeping are not being finalized, as
described in Unit V.M.
N. Options for Implementing the Rule
1. Final regulations. In the preamble
to the proposed rule, EPA discussed
three options for implementing the
refillable container and repackaging
standards, which were all in one
subpart in the proposed rule. These
options covered different approaches for
determining who would be held
responsible for ensuring that the
refillable containers meet the refillable
container standards. EPA considered
several options because the pesticide
products distributed or sold in refillable
containers and the containers
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themselves often enter the pesticide
distribution chain separately, so
identifying responsibility for
compliance is not as straightforward as
it is for nonrefillables, which the
registrants fill at their establishments.
In evaluating the options for container
design responsibility, EPA considered
the differences among the options in
terms of seeking the least burdensome
approach that is also effective,
practicable, and easily enforceable. In
the proposal, we identified Option 1 as
our preferred option (as indicated in the
proposed regulatory text) because we
thought it was more effective, more
practicable, and significantly more
easily enforceable than the other two
options. The three options are described
below.
• Option 1. Registrants would be
responsible for containers meeting the
design standards. The containers would
be marked ‘‘Meets EPA standards for
refillable pesticide containers’’ and
registrants would maintain records for
their containers. The registrants would
develop a list of acceptable containers
for each product, identified by
manufacturer and model number, and
provide the list to refillers. Refillers
could repackage pesticide only in
containers identified on the registrants
list.
• Option 2. Anyone could produce
containers, certify to EPA that the
containers meet EPA design standards,
and receive permission to mark
containers with EPA certification seal.
This could be container manufacturers,
but it could also be registrants, refillers,
or even end users. EPA would compile
a list of certified container models.
Registrants and refillers could repackage
products only into certified containers.
Registrants would develop a list of
acceptable container construction
materials for each product and provide
the list to refillers, who could refill only
into certified containers made from
materials identified as acceptable by the
registrant.
• Option 3. Container manufacturers
would be responsible for containers
meeting EPA’s design standards and
would mark containers with a
certification seal. Container
manufacturers would keep records for
containers. Registrants would develop a
list of acceptable container materials for
each product and provide the list to
refillers. Registrants and refillers would
repackage only into containers marked
with the seal and made of materials
identified as acceptable by the
registrant.
As discussed in the 1999
supplemental notice, EPA is
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implementing a combination of Option
1 and Option 3 in the final rule.
2. Changes. The key change from the
proposed rule is that the final
regulations adopt and refer to the DOT
standards for container design,
construction and marking, as discussed
in Unit IV. Therefore, registrants only
have to ensure that they use containers
that meet the cross-referenced DOT
standards for container integrity,
construction and testing, rather than
being responsible for the testing
themselves. Registrants must also
ensure compliance with the permanent
marking (serial number) and opening
(one-way valve/tamper-evident device)
requirements. Because containers will
be identifiable by the UN/DOT marking,
some of the repackaging standards can
be adjusted to be more flexible.
Specifically, rather than requiring the
registrants to identify acceptable
containers by the model numbers and
container manufacturers, they will be
able to identify acceptable containers by
the appropriate level of DOT testing
(Packing Group I, II or III) and the
container materials that are compatible
with the product. The general structure
of the repackaging standards, though,
remains as proposed: (1) Registrants are
responsible for developing certain
information and providing it to the
refillers; (2) refillers have certain
responsibilities for inspecting, cleaning,
and labeling the container since they are
the ones actually handling the
containers; and (3) both registrants and
independent refillers have certain
responsibilities if an independent
refiller repackages a registrant’s product.
The changes to the repackaging
regulations are discussed in more detail
in Unit VII.
VII. Repackaging Standards
A. Format Changes
Final regulation and changes. In the
proposed regulation, the refillable
container design standards and the
repackaging requirements were
included in the same subpart of the
regulations. In the final rule, EPA
moved the repackaging requirements
into a separate subpart because we think
separating the two kinds of
requirements will make the regulations
easier to understand. The container
design requirements are mostly
technical and apply mostly to
registrants. The repackaging
requirements are mostly procedural and
apply to registrants and to anyone who
repackages pesticide products into
refillable containers, which could be
registrants, distributors, retailers, or
other kinds of companies.
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In addition, the repackaging
requirements were reorganized so all of
the requirements that apply to a certain
kind of business are listed together.
Specifically, the requirements are listed
for: (1) Registrants who distribute or sell
pesticide products directly in refillable
containers; (2) registrants who distribute
or sell pesticide products to
independent refillers for repackaging;
and (3) independent refillers. The term
‘‘independent refiller’’ is used to
identify a refiller that is not part of the
registrant’s company. The differences
between these categories are described
in more detail below in Unit VII.C. This
format requires some standards to be
repeated. For example, the container
inspection requirement applies to
registrants who distribute or sell
pesticide products directly in refillable
containers and to independent refillers,
so the inspection requirement is
repeated. Despite the repetition, EPA
believes this regulatory structure is
more clear and easier to understand.
B. Purpose (§ 165.60(a))
1. Final regulations. The purpose of
the repackaging standards is to establish
requirements for repackaging some
pesticide products into refillable
containers for distribution or sale.
2. Changes. This is nearly the same as
the proposed purpose (in § 165.120(b)).
One minor change was to acknowledge
the reduced number of products that are
subject to the final regulations by stating
that the rule applies only to repackaging
some pesticide products. The proposed
regulations would have applied to all
products. Another insignificant
modification was to delete the term
‘‘standards’’ from the phrase ‘‘establish
standards and requirements’’ because it
is redundant.
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C. Who Must Comply (§§ 165.60(b),
165.65(a), 165.67(a), and 165.70(a))
1. Final regulation. You must comply
with the repackaging regulations if you
are a:
• Registrant who distributes or sells a
pesticide product in refillable
containers. This means that you conduct
all of the repackaging for a pesticide
product and that you do not distribute
or sell your pesticide product to a
refiller that is not part of your company
for repackaging into refillable
containers.
• Registrant who distributes or sells a
pesticide product to a refiller that is not
part of your company for repackaging
into refillable containers.
• Refiller of a pesticide product and
you are not the registrant of the
pesticide product.
As explained in Units VII.J. and
VII.K., a registrant may repackage a
product directly into refillable
containers for sale or distribution and
distribute or sell that same product to an
independent refiller for repackaging. In
this case, the registrant must comply
with both sets of requirements.
2. Changes. The same kinds of
businesses that were included in the
proposed rule (in § 165.122(a)(1), (2)
and (3)) are subject to the final rule. One
minor modification was to clarify that
refillers in the last two categories are
refillers that are not part of the
registrant’s company. Registrants can
also be refillers, which is the situation
described in the first category; the
registrant conducts all of the packaging
and repackaging. Therefore, the changes
are intended to clarify that the second
and third category refer to independent
refillers, i.e., refillers that are not part of
the registrant’s company.
D. Compliance Dates (§ 165.60(c))
1. Final regulations. The final
regulations provide a 5–year period after
the date of publication of the final rule
in the Federal Register before
compliance with the repackaging
standards is required. Specifically,
within 5 years from today’s date, all
products sold in refillable containers
must be distributed or sold in
compliance with these regulations.
2. Changes. Based on the comments
relating to refillable container design as
described in Unit VI.D., EPA decided to
extend the compliance period for the
refillable container regulations from the
2–year time frame that was proposed in
§ 165.139. The longer time frame is to
provide for a smoother and less
burdensome transition for companies.
Because the repackaging regulations
require pesticide product to be
repackaged only into containers that
meet the refillable container standards,
the compliance date for these
regulations needed to be changed for
consistency.
E. Pesticide Products Included
(§ 165.63(a) - (g))
1. Final regulations. As described in
detail in Unit III., only certain products
have to comply with the repackaging
standards. MUPs, plant-incorporated
protectants, and certain antimicrobial
products are completely exempt from
the repackaging requirements. All other
pesticide products are subject to the
repackaging regulations. This is
identical to the scope of the refillable
container regulations.
Some of the antimicrobial pesticides
that are subject to the repackaging
regulations are subject to a reduced set
of regulations. In particular,
antimicrobial pesticides that are used in
swimming pools and closely related
sites (such as hot tubs, spas and
whirlpools) are exempt from certain
recordkeeping requirements, as well as
the parts of the standards for inspecting
and cleaning containers that relate to
serial numbers, one-way valves, and
tamper-evident devices.
2. Changes. In the proposed rule, only
MUPs were exempt from the
repackaging requirements, which were
included in the refillable container
regulations (see § 165.122(b)(1)). All
other products would have been subject
to the standards. The 1999
supplemental notice discussed
regulatory options for exempting some
products (antimicrobials and nonantimicrobials) from the full set of
refillable container regulations
including the repackaging requirements
and for exempting certain antimicrobial
products from specific requirements.
The criteria in the final rule for
exempting antimicrobials are different
than those discussed in the
supplemental notice and the final rule
exempts plant-incorporated protectants.
The final repackaging regulations do not
incorporate the toxicity category,
container size or environmental hazard
criteria from the supplemental notice.
Also, the final rule changes some
aspects of the supplemental notice
approach of subjecting antimicrobial
swimming pool products to a reduced
set of requirements.
The following table describes the
provisions for determining which
pesticide products are subject to the
repackaging regulations and a brief
explanation of how (or if) this provision
changed from the proposal and/or the
supplemental notice.
TABLE 15.—CHANGES TO THE SCOPE OF THE REPACKAGING REGULATIONS
Regulatory Provision
Changes
Manufacturing use products are exempt.
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TABLE 15.—CHANGES TO THE SCOPE OF THE REPACKAGING REGULATIONS—Continued
Regulatory Provision
Changes
Plant-incorporated protectants are exempt.
Plant-incorporated protectants would have been subject to the proposed rule.
The regulations for plant-incorporated protectants were finalized in 2001.
We are exempting them from the final rule because of their unique nature.
Certain antimicrobial products are exempt.
Antimicrobial products would have been subject to the proposed rule. The
final rule implements an approach similar to option 1 in the supplemental
notice, although some of the details are different.
All other products are subject to all of the repackaging requirements, except for certain antimicrobial swimming pool products.
All products other than manufacturing use products would have been subject
to the proposed rule. The final rule is different than the approach discussed in the supplemental notice, which would have exempted products
in Toxicity Category III or IV in small containers and outdoor use products
without the specified environmental hazard statements on their label.
Antimicrobial products used in swimming pools and closely related sites are subject to a reduced set of repackaging requirements.
Antimicrobial products used in swimming pools would have been subject to
the proposed rule. The final rule is the result that was intended in the supplemental notice, although the specifics of how it is implemented in the
final rule are different than in the supplemental notice.
F. Other Exemptions (§ 165.63(h))
1. Final regulations. The repackaging
regulations do not apply to transport
vehicles that contain pesticide in
pesticide-holding tanks that are an
integral part of the transport vehicle and
that are the primary containment for the
pesticide or to containers that hold
gaseous pesticides. In addition, the final
rule includes a statement that clearly
exempts custom blending from the
repackaging requirements.
2. Changes. The exemption for
transport vehicles is identical to the
exemption proposed in § 165.122(b)(2)
and the exemption included in the final
refillable container regulations. The
exemption for custom blending was not
included in the proposed regulatory
text. It is discussed in Unit VII.L. In
addition, the final rule includes a
specific exemption for gaseous
pesticides, which is necessary to
implement our intent from the proposal
because the final rule does not use the
proposed terms liquid minibulk, dry
minibulk, liquid bulk and dry bulk
containers, which would have excluded
gaseous pesticides.
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G. Legal Basis for Repackaging Pesticide
Products for Distribution or Sale
Before continuing with a section-bysection analysis of the regulations, EPA
believes it is necessary to address three
broad issues regarding repackaging
pesticide products into refillable
containers: (1) The legal basis for
repackaging pesticide products (and the
related Bulk Pesticides Enforcement
Policy); (2) the integrity and purity of
products sold or distributed in refillable
containers; and (3) whether pesticides
can be repackaged at locations other
than registered establishments.
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1. Background. FIFRA section 3(a)
provides in pertinent part that ‘‘no
person in any State may distribute or
sell to any person any pesticide which
is not registered under this Act.’’
Registration is the principal means of
ensuring that a product is brought under
the FIFRA regulatory scheme. The
registrant must demonstrate to EPA’s
satisfaction that the product meets the
statutory criteria for registration with
respect to composition, labeling, and the
lack of unreasonable adverse effects.
The registrant must take responsibility
for quality control of the product’s
composition and for adequate labeling
describing the product, its hazards, and
its uses. Repackaging a pesticide
produces a new pesticide product that
must be registered before it can be
distributed or sold.
Before a pesticide product that is not
included within the terms of an existing
registration enters the channels of trade,
a separate registration must be obtained.
Changes in the formulation of a
registered product, changes in accepted
labeling, as well as any repackaging of
a pesticide into another container
activate the registration requirement,
unless the purposes of product
registration would be fully met by
carrying forward the Federal registration
of the constituent product.
In 1977, EPA issued an enforcement
policy for bulk shipments of pesticides.
(Ref. 75) The policy describes certain
conditions in which EPA allows the
transfer and repackaging of bulk
pesticides to occur without requiring
registration of the repackaged
pesticides. The 1977 Bulk Pesticides
Enforcement Policy (the Policy) defined
‘‘bulk’’ for the purposes of the Policy as
‘‘any volume of pesticide greater than 55
gallons or 100 pounds held in an
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individual container.’’ EPA developed
the Policy to accommodate business
practices of manufacturers and
distributors who handle pesticides in
large undivided quantities rather than in
small individual containers because of
the environmental and logistical
benefits associated with refillable
containers.
In the Policy, EPA determined that
repackaging of bulk pesticides could
occur without a separate registration if
certain conditions were met that would
assure that the purposes of registration
would be satisfied. The conditions are
that repackaging of the registered bulk
pesticides could involve nothing more
than changing the product container;
i.e., no change in: (1) The pesticide
formulation, (2) the pesticide’s labeling
except to add an appropriate statement
of net contents and a registered
establishment number, and (3) the
identity of the party accountable for the
product’s integrity.
The Policy elaborated on the
accountability requirement and set out
that the pesticide had to be: (1)
transferred at an establishment owned
by the registrant; or (2) transferred at a
registered establishment operated by a
person under contract with the
registrant; or (3) transferred at a
registered establishment owned by a
party not under contract to the product
registrant, but who had been furnished
written authorization for use of the
product label by the registrant. The
requirement for written authorization
assures that the registrant remains
responsible for quality control of the
product’s composition and adequate
labeling describing the product, its
hazards, and its uses.
The 1977 Policy only addressed the
transfer of a volume of pesticide greater
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than 55 gallons or 100 pounds held in
an individual container. In March 1991,
the Policy was amended (Ref. 71) to
allow repackaging of any quantity of
pesticides into refillable containers,
provided that all three conditions below
are met:
(1) The container is designed and
constructed to accommodate the return
and refill of greater than 55 gallons of
liquid or 100 pounds of dry material.
(2) Either: (a) The containers are
dedicated to and refilled with one
specific active ingredient in a
compatible formulation; or (b) the
container is thoroughly cleaned
according to written instructions
provided by the registrant to the dealer
prior to introducing another chemical
into the container, in order to avoid
cross-contamination.
(3) All other conditions of the July 11,
1977 Policy are met.
As discussed in the preamble of the
proposed rule, EPA is replacing the
Bulk Pesticides Enforcement Policy
with these regulations, specifically
§§ 165.67(b) - (c) and 165.70(b) - (c).
These regulations provide that a
registrant may allow an independent
refiller to repackage the registrant’s
pesticide product into any size refillable
container and to distribute or sell such
repackaged product under the
registrant’s registration (i.e., the
product’s EPA registration number stays
the same), provided all conditions set
out in the rule are met.
These regulations do not change the
existing law; the Bulk Pesticides
Enforcement Policy would be replaced
by a regulation. The registrant remains
responsible for the integrity, labeling,
and packaging of the repackaged
product. Both the registrant and
independent refiller may be held liable
for violations pertaining to the
repackaged product. The repackaging
regulations set out the requirements for
both registrants and independent
refillers, because they have different
roles and responsibilities in distributing
pesticide products in refillable
containers.
The conditions set out in §§ 165.67(b)
- (c) and 165.70(b) - (c) do not apply to
registrants repackaging their own
pesticide products solely at their own
establishments. As described in
Pesticide Registration (PR) Notice 98–10
‘‘Notifications, Non-notifications and
Minor Formulation Amendments,’’ the
registrant generally can modify the
package size and label net contents
statement without notifying EPA. (Ref.
56) This would be an amendment to the
registration not requiring EPA
notification or approval.
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2. Final regulations. The regulations
implementing the legal basis for
repackaging are similar to the provisions
in the proposed rule with two
significant changes, described in the
next section, and some minor formatting
modifications. Specifically, §§ 165.67(b)
and 165.70(b) specify that a registrant
may allow a refiller to repackage a
pesticide product into refillable
containers and to distribute or sell such
repackaged product under the existing
registration if all of the following
conditions are satisfied:
• The repackaging results in no
change to the pesticide formulation.
• One of the following conditions
regarding a registered refilling
establishment is satisfied:
(1) The pesticide product is
repackaged at a refilling establishment
registered with EPA as required by
§ 167.20 of this chapter.
(2) The pesticide product is
repackaged at the site of a user who
intends to use or apply the product by
a refilling establishment registered with
EPA as required by § 167.20.
• The registrant has entered into a
written contract with the refiller to
repackage the pesticide product and to
use the label of the pesticide product.
• The pesticide product is repackaged
only into refillable containers that meet
the standards of subpart C.
• The pesticide product is labeled
with the product’s label with no
changes except the addition of an
appropriate net contents statement and
the refiller’s EPA establishment number.
In addition, the regulations
(§§ 165.67(c) and 165.70(c)) state that
repackaging a pesticide product for
distribution or sale without either
obtaining a registration or meeting all of
the conditions listed above is a violation
of section 12 of FIFRA. Both the
registrant of the product and the refiller
that is repackaging the pesticide product
under contract to the registrant may be
liable for violations pertaining to the
repackaged product.
3. Changes. One significant change to
these conditions for repackaging
pesticide products for distribution or
sale is to add the specification that the
pesticide product can be repackaged by
a registered refilling establishment at
the site of a user who intends to use or
apply the product as an acceptable
alternative to the condition that the
product must be repackaged at a
registered refilling establishment. This
change is discussed in detail in Unit
VII.I. below. Another change is that the
final rule specifies that the registrant
must enter into a written contract with
the refiller. The proposed option for the
registrant to enter into a ‘‘written
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authorization’’ with the refiller is not
being finalized for several reasons. First,
EPA believes it is not necessary to have
two different mechanisms. It is more
straightforward to specify one method,
which should facilitate compliance and
minimize confusion. Second, EPA
believes that a ‘‘written contract’’ is
more familiar to the regulated
community and more defined in law
than a ‘‘written authorization,’’ which is
why we chose to specify contracts as the
mechanism for establishing a
repackaging relationship between the
registrant and refiller in the final rule.
Third, in the years since the Bulk
Pesticides Enforcement Policy was
issued, the ‘‘written authorizations’’
have become virtually indistinguishable
from ‘‘written contracts’’ in format,
length and level of detail. Therefore,
EPA anticipates that specifying a
contract (and not an authorization) in
the final rule should not cause a
substantial impact to the way
repackaging is currently being
conducted, particularly considering the
5–year implementation period for the
refillable container and repackaging
regulations. The other modifications
were minor formatting changes that
were needed to accommodate: (1) the
revision to plain language; (2) needing
to include the conditions in the
requirements for registrants who
distribute or sell to independent refillers
and in the requirements for independent
refillers; and (3) clarifying that the EPA
establishment number added to the
label is the refiller’s EPA establishment
number.
4. Comments - implementation. One
registrant urged EPA not to eliminate
the ability of manufacturers and
distributors that are not registrants of an
MUP to repackage that product for
distribution and sale.
5. EPA response - implementation. In
the preamble to the proposed
regulations, EPA stated that the Bulk
Pesticides Enforcement Policy would
remain in effect until the date specified
for compliance with the refillable
container and repackaging regulations,
at which point it would be rescinded.
EPA will implement this as discussed in
the preamble to the proposal. The
refillable container and repackaging
regulations will supersede the Bulk
Policy for products that are subject to
these regulations. Pesticide products
that are exempt from the refillable
container and repackaging regulations-MUPs, plant-incorporated protectants,
and some antimicrobials--can only be
repackaged under the limitations
established by FIFRA, the registration
requirements in 40 CFR part 152, and
the applicable OPP policies. A key
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limitation is that the products that are
exempt from the refillable container and
repackaging regulations must be
repackaged by the registrant or a person
under written contract to the registrant.
EPA believes this constraint will not be
a problem for MUPs and exempt
antimicrobials because we have
received information that these products
are repackaged by the registrants if they
are sold or distributed in refillable
containers. In addition, refillable
containers are not appropriate for
distributing plant-incorporated
protectants, so these products will also
not be adversely affected.
One issue that has been raised is
whether registrants and independent
refillers can comply with the regulations
(and specifically the conditions for
repackaging pesticide products for
distribution or sale) before the
compliance date. This is appealing to
registrants and independent refillers
because the regulations allow pesticides
to be repackaged under written
contracts into refillable containers of
any size (compared to the 55 gallon
container size limit established in the
Bulk Policy and maintained in the 1991
amendment). EPA believes that it is
acceptable for registrants and
independent refillers to repackage
pesticide products under the regulations
before the 5 year compliance date as
long as they are in full compliance with
the refillable container and repackaging
regulations. In other words, registrants
can enter into contracts with
independent refillers to refill containers
only if: (1) The containers comply with
the refillable container regulations, i.e.,
they meet the specified DOT standards,
have a durable serial number or other
identifying code, and have one-way
valves and/or tamper-evident devices;
(2) the registrant meets the repackaging
conditions and develops and provides
the necessary information, including a
description of acceptable containers and
a cleaning procedure; (3) the refillers
meet the repackaging conditions and
comply with the operational
procedures, including inspecting,
cleaning (if necessary), and labeling the
containers; and (4) all other
requirements specified in the refillable
container and repackaging regulations
are followed.
H. Product Integrity
1. Background. The Bulk Pesticides
Enforcement Policy and both the
proposed and final rules hold the
registrant and the refiller (if different
than the registrant) responsible for
product integrity of the pesticide
product repackaged by the refiller.
‘‘Product integrity’’ means that the
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pesticide product is not adulterated or
different from the composition
described in its confidential statement
of formula that is required under FIFRA
section 3. This requirement reflects
current law. Under FIFRA section
12(a)(1), it is unlawful for any person to
distribute or sell to any person a
pesticide which is adulterated or whose
composition differs from the
composition described in its
confidential statement of formula.
FIFRA Section 12(a)(1) applies to
pesticide distributed or sold in
nonrefillable containers and in refillable
containers. For pesticides distributed or
sold in nonrefillable containers, it is
clear that the registrants are responsible
for product integrity because there are
no other parties involved (except for
supplemental registrants, as regulated
by 40 CFR 152.132, and parties acting as
agents under contract to the registrant).
Similarly, when a registrant repackages
a product directly into a refillable
container for distribution or sale, it is
also clear that the registrant is
responsible for product integrity.
The situation is less clear when a
registrant distributes or sells a product
to an independent refiller for
repackaging into refillable containers.
Both the registrants and the
independent refillers are selling or
distributing the product, so both parties
are responsible for product integrity.
The registrant is responsible because the
registrant has authorized the
independent refiller to repackage the
registrant’s pesticide product and to use
the registrant’s label according to the
terms of the written contract (or
authorization under the Bulk Policy).
The registrant remains accountable for
its repackaged product which is
distributed or sold in the refillable
container. EPA believes it is appropriate
for registrants to be held responsible for
acts by independent refillers because
the repackaging is being done under the
registrant’s registration and the
independent refillers are agents of the
registrants for purposes of carrying out
the written contract. The independent
refiller is responsible for product
integrity because the refiller is the
person who physically places the
product into the container for sale or
distribution.
In 1996, EPA established a policy on
‘‘Toxicologically Significant Levels of
Pesticide Active Ingredients’’ in PR
Notice 96–8. (Ref. 58) This document
describes EPA’s interpretation of the
term ‘‘toxicologically significant’’ as it
applies to contaminants in pesticide
products that are also active ingredients.
The policy provides risk-based
concentration levels of such
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contaminants that are generally
considered to be toxicologically
significant (and therefore must be
reported and accepted as part of product
registration according to 40 CFR
158.167). The concentrations are
defined according to the type of
pesticide that is contaminated
(insecticide, herbicide, low dose
herbicide, etc.) and the pesticide
category of the contaminant. While PR
Notice 96–8 applies to all pesticide
products in nonrefillable and refillable
containers, a driving force in developing
the policy was the cross-contamination
found in refillable containers in the
early 1990’s.
2. Final regulations. The repackaging
regulations clearly hold all parties
subject to the repackaging standards to
be responsible for product integrity.
This includes:
(1) Registrants who distribute or sell
a pesticide product in refillable
containers (in § 165.65(b));
(2) Registrants who distribute or sell
pesticide products to independent
refillers for repackaging into refillable
containers (in § 165.67(e)); and
(3) Refillers of a pesticide product that
are not the registrants of the pesticide
product (in § 165.70(d)).
Specifically, all of these businesses
are responsible for the pesticide product
that they distribute or sell not being
adulterated or different from the
composition described in the product’s
confidential statement of formula that is
required under FIFRA section 3.
3. Changes. The language in the final
regulation is nearly identical to the text
in the proposed regulation. One slight
modification is that the phrase
‘‘described in its confidential statement
of formula that is required under FIFRA
section 3’’ is used in the final
regulations because it is more
straightforward than the proposed
phrase ‘‘described in the statement
required in connection with registration
under section 3 of the Act.’’ EPA
considers these two phrases to mean
exactly the same thing.
However, one thing that has changed
since the proposed rule is EPA’s policy
on toxicologically significant levels of
pesticide active ingredients. PR Notice
96–8 defines risk-based concentration
levels of contaminants that are generally
considered to be toxicologically
significant. Active ingredient
contaminants that are present at lower
concentrations do not have to be
reported by registrants and accepted by
EPA as part of product registration. For
example, if an herbicide active
ingredient is detected at less than 1,000
ppm in any pesticide where the
contaminant is accepted for use on all
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sites for which the product is labeled,
the herbicide active ingredient is not
considered to be toxicologically
significant. As described in PR Notice
96–8, the purpose of this policy is to: (1)
Recognize that cross-contamination is a
reality, and that not all crosscontamination is problematic; (2) set a
clear standard that can be readily
applied by EPA, States and the
regulated industry; (3) ensure that
allowable cross-contamination does not
pose unreasonable adverse effects; (4)
minimize the paperwork burden for
EPA and registrants; (5) maintain
accountability for the product from the
registrant to the end user; and (6) not
preclude marketplace or private
solutions to correct problems that do
arise.
I. Delivery and Repackaging at End User
Locations
1. Background. The 1977 Bulk Policy
(Ref. 75) provided the following two
examples of acceptable practices for
shipping ‘‘bulk’’ pesticides to end users:
• A registrant ships a bulk pesticide
directly to an end user (custom
applicator, farmer, etc.). The label
accompanies the shipment and is placed
on the user’s tank. No new
establishment or product registration is
needed for the bulk container since the
labeled product is fully registered and
has been sold intact to the user.
• A tank car of pesticide from which
commercial applicators meter off into
their own tanks, without being put into
a dealer’s holding tank, would be
exempt from new producer
establishment registration. It is
considered that the original container
has not been changed in delivery to the
applicator and the tank car label
(placard) will bear the producer’s
establishment number.
In the preamble to the 1994 proposed
rule, EPA stated that repackaging by the
registrant must be done at a registered
establishment, as required by 40 CFR
part 167. In addition, EPA stated that we
saw no reason to continue the
exemption from the registered
establishment requirement described in
the second bullet in Unit I.1., above. We
requested comments on the effect of
discontinuing this exception.
On February 3, 1994, EPA released
the ‘‘Bulk Pesticide Repackaging
Question & Answer Document’’ (Ref. 63)
which included the following question
and answer that address the issue of
making a bulk delivery directly to an
end user.
18. May a registrant deliver pesticides in
bulk directly to a farm, even if the farm is not
registered as a producing establishment? May
someone other than the registrant do this?
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Under the bulk pesticide repackaging
policy, a registrant may deliver pesticides
directly to a farm, even if the farm is not
registered as a pesticide producing
establishment. Someone other than the
registrant could not deliver pesticides in bulk
to a farm unless the farm was registered as
a pesticide producing establishment and that
person has received written authorization
from the registrant to deliver the pesticide to
the specific farm. The registrant of the
establishment (i.e., the farmer) would also be
required to submit annual production
reports. Please note that some States and
most registrants require containment
structures for the storage of bulk pesticides.
Most farmers do not have these containment
structures and delivery to these farms may
not be allowed under State law.
After discussion and debate on this
question among the regulated
community and regulatory agencies,
EPA reconsidered and revised our
position in a memo titled ‘‘Bulk
Pesticide Transfers’’ dated March 22,
1995. (Ref. 59) The new question 18
supersedes the question in the 1994
Bulk Policy Question & Answer
document and is:
18(a). May a registrant deliver pesticides in
bulk directly to a farm, even if the farm is not
registered as a producing establishment? May
someone other than the registrant do this?
A registrant, dealer, or other authorized
person pursuant to the ‘‘Enforcement Policy
Applicable to Bulk Shipments of Pesticides’’
(July 11, 1977) may transfer pesticides in
bulk at a farm, even if the farm is not
registered as a pesticide producing
establishment.
18(b). May a registrant deliver pesticides in
bulk directly to end use sites other than a
farm, even if such site is not registered as a
producing establishment? May someone
other than the registrant do this?
Yes. See answer to question 18(a) above.
However, the Agency will continue to pursue
enforcement actions against all end users that
use any registered pesticide in a manner
inconsistent with its labeling pursuant to
FIFRA 12(a)(2)(G).
The March 22, 1995 memo explained
that this revision was made because end
users are not the persons repackaging
shipments of bulk pesticides at the farm
and other end use sites. The memo
further stated that the terms and
conditions of the 1977 Bulk Policy and
1991 amendment are unchanged. Since
the pesticide that is transferred at the
farm or other end use site is not being
transferred and held for further sale,
final accountability for meeting the
terms of the Bulk Policy remains with
the registrant and the last establishment
making a transfer associated with a
pesticide sale, the dealer. Registrant and
dealer establishments are responsible
for reporting repackaging as production
pursuant to 40 CFR 167.85. In the
memo, EPA recommended (but did not
require) that pesticides be transferred
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into stationary bulk containers protected
by a secondary containment structure at
end user sites.
2. Final Regulation. One of the
requirements specified in §§ 165.67(b)
and 165.70(b) for when a registrant may
allow a refiller to repackage its pesticide
product into refillable containers and to
distribute or sell such repackaged
product under the existing registration
is:
One of the following conditions
regarding a registered refilling
establishment is satisfied:
(1) The pesticide product is
repackaged at a refilling establishment
registered with EPA as required by
§ 167.20.
(2) The pesticide product is
repackaged at the site of a user who
intends to use or apply the product by
a refilling establishment registered with
EPA as required by § 167.20.
3. Changes. The first condition listed
above (Unit I.2.(1)) (the product is
repackaged at a registered refilling
establishment) is the same as the
proposed regulation. The second
condition--the product is repackaged at
the site of a user who intends to use or
apply the product by a registered
refilling establishment--was added to
the final rule to be consistent with
EPA’s revised policy as described in the
March 22, 1995 ‘‘Bulk Pesticide
Transfers’’ memo. The final regulation is
consistent with EPA’s 1995 position that
final accountability for meeting the
terms of the Bulk Policy remains with
the registrant and the last establishment
making a transfer associated with a
pesticide sale (an independent refiller in
this case), because the pesticide that is
transferred at the farm or other end use
site is not being transferred and held for
further sale.
EPA has received anecdotal evidence
that the practice of refilling containers
(bulk containers, minibulks, application
tanks, nurse tanks, etc.) at end user sites
has increased over the past few years
and may continue to increase in the
future. Therefore, EPA is concerned
about the potential for spills, leaks and
other releases during transfers at end
user sites to cause soil and water
contamination. As described in the
preamble to the proposed rule, EPA
decided to require containment
structures at dealers, commercial
applicators and custom blenders with
bulk storage tanks, largely because these
were the kinds of sites where
contamination had been documented.
EPA did not and still does not have
documentation of end user site
contamination due to repackaging
pesticide product. Therefore, the final
pesticide container and containment
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regulations do not require repackaging
at end user sites to be done within a
containment structure. However, EPA
strongly recommends that repackaging
at end user sites be conducted over
some kind of containment--whether it is
a permanent concrete containment pad
or a portable containment structure. In
the future, EPA may revise the
repackaging regulations to require all
repackaging (including at end user sites)
to occur over a containment structure if
we become aware of a pattern of end
user site contamination being caused by
repackaging.
J. Registrants Who Distribute or Sell
Pesticide Products in Refillable
Containers - Overview (§ 165.65)
1. Final Regulation. The regulations in
§ 165.65 apply to registrants who
distribute or sell pesticide products in
refillable containers. This means that
the registrant conducts all of the
repackaging for the product and does
not distribute or sell the product to a
refiller that is not part of its company
for refilling.
Of course, a registrant may repackage
a product directly into refillable
containers for sale or distribution and
distribute or sell that same product to an
independent refiller for repackaging. In
this case, the registrant must comply
with both sets of requirements: the
standards in § 165.65 for those
quantities the registrant distributes or
sells directly in refillable containers and
the requirements in § 165.67 for those
quantities that the registrant distributes
or sells to independent refillers for
repackaging.
A registrant who distributes or sells a
pesticide product directly in refillable
containers:
• Is responsible for the integrity of the
product, as discussed in Unit VII.H.;
• Must develop a refilling residue
removal procedure, as discussed in Unit
VII.M.;
• Must develop a description of
acceptable containers, as discussed in
Unit VII.N.;
• Must comply with the requirements
for refillers (including having certain
information and inspecting, cleaning,
and labeling the refillable containers), as
discussed in Unit VII.O. through VII.R.;
• Must keep records, including copies
of the refilling residue removal
procedure and the description of
acceptable containers and certain
information about each instance of
repackaging. The recordkeeping
requirements are discussed in Unit
VII.S.
2. Changes. All of these requirements
for registrants who distribute or sell
pesticide products directly in refillable
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containers were included in the
proposed regulation. Some of the
requirements were modified based on
comments and the change to refer to and
adopt some of the DOT standards. The
specific changes to these requirements
are discussed in other sections of Unit
VII.
K. Registrants Who Distribute or Sell
Pesticide Products to Refillers for
Repackaging - Overview (§ 165.67)
1. Final Regulation. The regulations in
§ 165.67 apply to registrants who
distribute or sell pesticide products to
refillers that are not part of their
companies for repackaging into
refillable containers. This is the more
common form of repackaging, where the
registrant ships in bulk to a refiller
(normally a retailer) who repackages the
product into portable pesticide
containers.
As mentioned above, a registrant may
repackage a product directly into
refillable containers for sale or
distribution and distribute or sell that
same product to an independent refiller
for repackaging. In this case, the
registrant must comply with both sets of
requirements: the standards in § 165.65
for those quantities the registrant
distributes or sells directly in refillable
containers and the requirements in
§ 165.67 for those quantities that the
registrant distributes or sells to
independent refillers for repackaging.
A registrant who distributes or sells a
pesticide product to an independent
refiller for repackaging:
• Must comply with the conditions
for allowing a refiller to repackage his
product, as discussed in Unit VII.G.;
• Must provide the refiller with the
written contract to repackage before
distributing or selling the product to the
refiller;
• Is responsible for the integrity of the
product, as discussed in Unit VII.H.;
• Must develop a refilling residue
removal procedure, as discussed in Unit
VII.M.;
• Must develop a description of
acceptable containers, as discussed in
Unit VII.N.;
• Must provide the refilling residue
removal procedure, description of
acceptable containers, and the product’s
label and labeling to the refiller before
or at the time of distribution or sale to
the refiller;
• Must keep records of the contracts,
the refilling residue removal procedure,
and the description of acceptable
containers. The recordkeeping
requirements are discussed in Unit
VII.S.
The requirements that are specific to
registrants who distribute or sell
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pesticide products to independent
refillers for repackaging are the two that
establish standards for the timing of
when the registrant provides documents
to the refiller. Under § 165.67(d), the
registrant must provide the written
contract to repackage the product before
selling or distributing the product to the
refiller. Section 165.67(g) specifies that
the other information (cleaning
procedure, description of acceptable
containers, and label/labeling) can be
provided earlier but must be provided to
the refiller at the time of sale or
distribution at the latest. These two
provisions are identical to the proposed
regulations.
2. Changes. All of these requirements
for registrants who distribute or sell
pesticide products to refillers for
repackaging were included in the
proposed regulation. Some of the
requirements were modified based on
comments, modifications to some EPA
policies, and the change to refer to and
adopt some of the DOT standards. The
specific changes to these requirements
are discussed in other sections of Unit
VII.
L. Refillers Who Are Not Registrants Overview (§ 165.70)
1. Final Regulation. The regulations in
§ 165.70 apply to refillers who are not
registrants of the products that they
repackage for sale or distribution.
A refiller who repackages a product
for distribution or sale and is not the
registrant of the product:
• Must comply with the conditions
for allowing him to repackage the
registrant’s product, as discussed in
Unit VII.G.;
• Is responsible for the integrity of the
product, as discussed in Unit VII.H.;
• Must comply with the requirements
for refillers (including having certain
information and inspecting, cleaning,
and labeling the refillable containers), as
discussed in Unit VII.O. through VII.R.;
• Must keep records, including copies
of the contract from the registrant,
refilling residue removal procedure, and
description of acceptable containers,
and certain information about each
instance of repackaging. The
recordkeeping requirements are
discussed in Unit VII.S.
2. Changes. All of these requirements
for independent refillers were included
in the proposed regulation. Some of the
requirements were modified based on
comments, modifications to some EPA
policies, and the change to refer to and
adopt some of the DOT standards. The
specific changes to these requirements
are discussed in other sections of Unit
VII.
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3. Comments - whether or not to
include custom blending in this rule. In
the preamble to the proposed rule, EPA
discussed whether or not the
requirements for independent refillers
should apply to custom blenders, who
provide the service of mixing pesticides
with fertilizer, feed, or another pesticide
to a customer’s specification. The
preamble provided two options for the
final rule: (1) Issue a regulation on
refilling practices that is tailored
specifically to custom blenders that
distribute pesticide mixtures, or (2)
exempt custom blenders from the
repackaging requirements. EPA
requested comments on these options.
A few commenters showed lukewarm
support for applying the repackaging
regulations to custom blenders. A
registrant was unaware of pressing
reasons to exclude custom blenders and
pointed out that custom blenders are
usually custom applicators. A State
regulatory agency stated that custom
blenders should be required to meet the
refilling requirements if the criteria
apply to them. This commenter also
pointed out that custom blends are
generally placed into a spreader, not a
container.
A registrant group stated that custom
blenders provide valuable service in
reducing pesticide container use and
applicator exposure. This respondent
recommended developing standards
that are specific to custom blenders and
that address items such as container
integrity and cleaning procedures.
A registrant distinguished between
custom blending and selling a pesticide
product in a refillable container with a
registrant’s label on it as two different
activities. A few dealer groups strongly
urged EPA to exclude custom
applicators from the refiller
requirements. The retailer-related
commenters believe it is inappropriate
to address custom blenders in a section
that focuses on maintaining the original
integrity of repackaged pesticides. They
also described current custom blending
practices in the Midwest, including the
following points:
• Midwest dealers with bulk
pesticides are mostly all custom
blenders and custom applicators and
have become repackagers recently.
• It is common for the volume of bulk
pesticides that goes into custom blends
to exceed the volume that is repackaged
into refillable containers.
• Custom blends may be loaded into
custom application and nurse vehicles
of that dealer, another for-hire custom
applicator, or a customer.
• On the other hand, registered bulk
pesticides are: (1) Repackaged into
minibulk containers; (2) moved in
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portable service containers from the
bulk container to supply the dealer’s
custom application operation in the
field; and (3) loaded into tanks that are
an integral part of application or nurse
vehicles for field nursing or to supply
injection systems.
4. EPA response - whether or not to
include custom blending in this rule. In
the final rule, EPA decided to exempt
custom blending from having to comply
with the repackaging requirements. As
stated by several of the commenters,
EPA determined that there is an
inherent difference between custom
blending and repackaging pesticide
products for sale or distribution. When
a product is repackaged for sale or
distribution, it must maintain the
characteristics of the product and meet
the ingredient contents identified on the
label and in the product’s registration.
On the other hand, a custom blend
intentionally mixes a pesticide with
another substance. While the product’s
labeling must be consistent with the
custom blend (i.e., the labeling
directions do not prohibit the use of the
product in such a blend) and the
product’s label must be delivered to the
end-user, the material in the custom
blend is no longer just the pesticide
product identified on the label. In fact,
the custom blender must deliver a
statement specifying the composition of
the mixture.
The exemption for custom blending
was added to § 165.63(h) of the final
regulation, which asks ‘‘Are there any
other exceptions?’’ Paragraph (h) in
§ 165.63 was added to state that custom
blending is exempt from the regulations
in this subpart. In addition, § 165.3 of
the regulations define custom blending
as ‘‘Custom blending means the service
of mixing pesticides to a customer’s
specifications, usually a pesticide(s)fertilizer(s), pesticide-pesticide, or a
pesticide-animal feed mixture, when:
(1) The blend is prepared to the order
of the customer and is not held in
inventory by the blender;
(2) The blend is to be used on the
customer’s property (including leased or
rented property);
(3) The pesticide(s) used in the blend
bears end-use labeling directions which
do not prohibit use of the product in
such a blend;
(4) The blend is prepared from
registered pesticides; and
(5) The blend is delivered to the enduser along with a copy of the end-use
labeling of each pesticide used in the
blend and a statement specifying the
composition of the mixture.’’
This description is based on the
definition of ‘‘custom blender’’ in 40
CFR 167.3, but was modified to reflect
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the practice of custom blending rather
than the establishment at which it takes
place. The § 167.3 definition focuses on
the establishment, because the part 167
regulations then exempt custom
blenders from the requirements to
register their establishments (in
§ 167.20(a)(1)) and to report production
(in § 167.85(a)). The § 167.3 definition of
custom blender includes a sixth
condition--that no other pesticide
production activity is performed at the
establishment--because these other
activities would subject a custom
blender to the establishment registration
and production reporting requirements.
However, this sixth condition is not
relevant to the pesticide product
repackaging requirements in 40 CFR
part 165 subpart D because the subpart
D regulations are tied to the process or
action of repackaging. As reported by
several commenters, a facility may
conduct several different activities,
including repackaging pesticide
products into refillable containers and
custom blending. In this case, the
repackaging must be conducted in
accordance with the regulations in this
subpart, while the custom blending is
exempt from the regulations in this
subpart.
It is worth noting that the
containment regulations in subpart E
apply to some custom blenders,
specifically ‘‘custom blenders of
agricultural pesticides.’’
5. Comments - mixing diluent with
pesticides. Several commenters (dealer
groups and a dealer) urged EPA to allow
water as a blend component. One
retailer described the awkwardness of
the situation when such mixing is not
permitted — a dealer can put pesticide
in a farmer’s application equipment at
its facility (with a containment pad), but
the farmer has to return to his own
location to add water and finish
preparing the application mixture. The
two dealer groups suggested or stated
that using water as a custom blend
component is currently practiced in the
Midwest. The two dealer groups also
recommended deleting condition #6 in
the § 167.3 definition of custom blender
which specifies that ‘‘no other pesticide
production activity is performed at the
establishment.’’
6. EPA response - mixing diluent with
pesticides. EPA disagrees with the
comment to delete condition #6 in the
§ 167.3 definition of custom blender that
specifies ‘‘no other pesticide production
activity is performed at the
establishment.’’ As described above, this
condition is intended to distinguish
between custom blenders - who are
exempt from the part 167 establishment
registration requirements - and
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producing establishments, who are
required to register their establishments.
Condition #6 does not prevent a facility
from conducting custom blending and
repackaging (producing). These facilities
must register as establishments because
they are producing establishments.
Instead, condition #6 is intended to
describe the facilities that are exempt
from the establishment registration
requirements, i.e., facilities that custom
blend and do not repackage or otherwise
produce pesticides.
However, EPA considered the request
from commenters to allow custom
blends to be diluted with water. Various
offices and Regions within EPA, as well
as the States, have not had a consistent
policy about whether custom blends can
be diluted with water or another
diluent. After reviewing this issue, it is
appropriate to clarify our position on
diluting custom blends. EPA believes
that the definition of custom blender in
§ 167.3 provides flexibility. Custom
blenders are defined as ‘‘any
establishment which provides the
service of mixing pesticides to a
customer’s specifications, usually a
pesticide(s)-fertilizer(s), pesticidepesticide, or a pesticide-animal feed
mixture, when’’ the six conditions
described above are met. In particular,
the word ‘‘usually’’ in this definition
provides flexibility and allows water (or
other diluents when specified by the
labeling of the pesticide[s] in the blend)
to be added to custom blends.
EPA believes that the language of
§ 167.3 allows custom blends to be
diluted with water or a diluent specified
on the labels of all pesticides in the
blend. In many ways, it is more efficient
and possibly more accurate for the
facility that is measuring and blending
pesticides, fertilizers and/or animal feed
to also measure and blend the diluent
into the custom blend. In addition,
custom blends (with diluents) that are
delivered to an end user as a usedilution (usually in refillable
containers) offer worker exposure and
environmental protection benefits
including eliminating the need for end
users to mix, handle and potentially
spill the pesticide in the field;
eliminating the need for the end user to
rinse containers in the field; allowing
the use of closed systems; and reducing
the number of nonrefillable containers
that must be disposed or recycled.
However, EPA wants to clarify that
custom blends with a diluent added still
must comply with all five conditions in
the definition of custom blend in
§ 165.3: ‘‘Custom blending means the
service of mixing pesticides to a
customer’s specifications, usually a
pesticide(s)-fertilizer(s), pesticide-
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pesticide, or a pesticide-animal feed
mixture, when:
(1) The blend is prepared to the order
of the customer and is not held in
inventory by the blender;
(2) The blend is to be used on the
customer’s property (including leased or
rented property);
(3) The pesticide(s) used in the blend
bears end-use labeling directions which
do not prohibit use of the product in
such a blend;
(4) The blend is prepared from
registered pesticides; and
(5) The blend is delivered to the enduser along with a copy of the end-use
labeling of each pesticide used in the
blend and a statement specifying the
composition of the mixture.’’
EPA will monitor the practices and
procedures that develop and proliferate
in the field with this interpretation. If
problems develop, EPA will consider
options, including revising its
interpretation, adding protective
conditions if diluents are added to
custom blends, and subjecting custom
blending to the repackaging
requirements in part 165.
In addition, EPA does not view a
difference between custom blending and
custom mixing from a regulatory point
of view. A custom mixer is a facility that
stores materials previously purchased
by end-users and that custom mixes the
products just prior to application. A
custom mixer does not own, sell or
apply the product, although the
conditions in the § 165.3 definition of
custom blending are met. Over the
years, there have been different
interpretations of whether or not there
is a difference between custom blending
and custom mixing. At least a few
businesses have been established as
custom mixers under the determination
that they are not custom blenders. This
final rule does not distinguish between
custom blenders and custom mixers.
Similarly, the policy of allowing
diluents to be added to custom blends
applies to both custom blenders and
custom mixers. As discussed above,
custom blending is excluded from the
subpart D repackaging requirements.
However, custom blenders (including
custom mixers) would be subject to the
subpart E containment standards if they
blend (mix) agricultural pesticides.
7. Comments - service containers. A
few dealer groups noted that the
proposed rule does not address service
containers, which are used to move
pesticides from bulk storage to end-use
applications in the field, e.g., the tanks
that are an integral part of application
or nurse vehicles. These commenters
pointed out some advantages of service
containers including: reducing the
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number of nonrefillable containers used,
keeping pesticides separate from water
or fertilizers during transportation,
accommodating on-board injection
systems and allowing the applicator to
adjust pesticides in the field. These
commenters urged EPA and industry to
consider providing for the expanded use
of service containers, with some
exclusions from the refillable container
requirements, to increase the use of bulk
pesticides. A State regulatory agency
supported keeping the Bulk Policy
because they don’t want to register each
facility where bulk pesticides are
metered, such as where pest control
operators place pesticides into service
containers.start here
8. EPA response - service containers.
The pesticide container and repackaging
regulations do not regulate service
containers, because the container and
repackaging regulations only apply to
containers that are used to sell or
distribute pesticide products and to the
repackaging of products for sale or
distribution. For the purposes of this
discussion, a service container is
defined as ‘‘any container used to hold,
store, or transport a pesticide
concentrate or a pesticide use-dilution
mixture, other than the original labeled
container in which the product was
distributed or sold, the measuring
device, or the application device.’’
EPA does not currently regulate
service containers. In 1976, EPA issued
a Pesticide Enforcement Policy
Statement (PEPS) on ‘‘Structural Pest
Control: Use and Labeling of Service
Containers for the Transportation or
Temporary Storage of Pesticides,’’
which defined minimal labeling
requirements and several other
limitations for the acceptable use of
service containers by structural pest
control operators. (Ref. 76) However,
this PEPS was later rescinded. EPA
continues to believe that it is a good
management practice to ensure that the
contents of service containers are
identified and that the label of a
pesticide product that is in a service
container is available to the person
handling and/or applying the pesticide.
EPA may consider developing a separate
policy on service containers while the
pesticide container and containment
regulations are being phased in.
M. Registrant Refilling Residue Removal
Procedure (§ 165.65(c)(1) and
165.67(f)(1))
1. Final Regulation. Registrants who
sell or distribute pesticide products
directly in refillable containers and
registrants who sell or distribute
products to independent refillers for
repackaging must develop a refilling
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residue removal procedure that
describes how to remove pesticide
residue from a refillable container
(portable or stationary pesticide
container) before it is refilled.
Registrants must specify a cleaning
procedure for each product sold or
distributed in refillable containers,
although the same procedure can be
used for multiple products. The refilling
residue removal procedure must
provide instructions for removing
residues from all refillable containers.
The same procedure can apply to
portable and stationary pesticide
containers, or the registrant can describe
different procedures if it is appropriate
and necessary. Finally, the refilling
residue removal procedure describes
how to remove residue from a refillable
container. While this generally involves
rinsing the container with water, the
regulations do not specifically require
rinsing with water. If a different
procedure is appropriate for a given
formulation, it can be used as long as it
meets the following performance
standard.
The refilling residue removal
procedure must meet the performance
standard of being adequate to ensure
that the composition of the pesticide
product does not differ at the time of its
distribution or sale from the
composition described in its
confidential statement of formula. This
standard ensures that the products
distributed and sold in refillable
containers meet the existing product
integrity requirements, as described in
Unit VII.H.
The refilling residue removal
procedure must describe how to manage
any rinsate resulting from the procedure
in accordance with applicable Federal
and State regulations if: (1) The
procedure requires the use of a solvent
other than the diluent used for applying
the pesticide, or (2) there is no diluent
used for application. This information is
necessary to help refillers manage
rinsate that cannot easily be used as
make-up water in future applications.
2. Changes. This requirement is the
same as it was in the proposed rule.
Several minor editing change have been
made to improve the clarity and the
different refillable containers are
described as portable and stationary
pesticide containers because the
definitions of minibulk and bulk are not
being finalized. These modifications
have not changed the requirement or
intent of the requirement.
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N. Registrant Description of Acceptable
Containers (§§ 165.65(c)(2) and
165.67(f)(2))
1. Final regulation. Registrants who
sell or distribute pesticide products
directly in refillable containers and
registrants who sell or distribute
products to independent refillers for
repackaging must develop a description
of acceptable refillable containers
(portable and stationary pesticide
containers) that can be used for
distributing or selling that pesticide
product. An acceptable container is one
which the registrant has determined
meets the refillable container standards
in subpart C and is compatible with the
pesticide formulation intended to be
distributed and sold using the refillable
container. The registrant must identify
the containers by specifying: (1) The
container materials of construction that
are compatible with the pesticide
formulation; and (2) information
necessary to confirm compliance with
the refillable container requirements in
subpart C. The refillable container
requirements include the adopted DOT
standards, being marked with a serial
number or other identifying code,
having a one-way valve or tamperevident device on each opening (other
than a vent) of a portable pesticide
container designed for liquids, and the
stationary pesticide container
requirements.
Similar to the refilling residue
removal procedure, registrants must
specify a description of acceptable
containers for each product sold or
distributed in refillable containers,
although the same description can be
used for multiple products if it meets
the standards.
2. Changes. This requirement was
changed significantly from the proposed
rule. The proposal would have required
registrants to develop lists (not
descriptions) of acceptable containers,
which would have been identified by
specifying the container manufacturer
and model number of the container.
This was proposed because registrants
are responsible for ensuring that the
refillable containers used to sell and
distribute their products meet the
requirements in the container
regulations. When EPA proposed the
rule, specifying the container
manufacturer and model number
seemed like a relatively easy way for
registrants to identify acceptable
containers for their refillers.
However, the final rule’s approach of
referring to and adopting some DOT
requirements provides an even easier
way for registrants to identify acceptable
containers to the refillers. Rather than
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citing specific model numbers, the
registrants can provide refillers with a
much less prescriptive approach by
identifying characteristics, such as the
material of construction, how to
determine if the container meets the
applicable DOT standards, how to
comply with the serial number
requirement, how to obtain and apply
one-way valves and/or tamper-evident
devices to the openings of portable
pesticide containers for liquids and
information for complying with the
stationary pesticide container standards.
3. Comments. Several commenters
(registrants and a registrant group)
recommended that instead of a list of
acceptable containers, the registrants
should identify acceptable containers by
providing the compatible materials of
construction and the necessary
information to apply the DOT standards.
The registrant group and a distributor
commented that this requirement will
be helpful to ensure that formulators
and subregistrants know and obtain
information about the proper packaging.
4. EPA response. In the final rule, EPA
changed the requirement for identifying
acceptable containers so registrants can
describe acceptable containers by
specifying compatible materials of
construction and the information
necessary to comply with the refillable
container requirements. This includes
information for complying with the
adopted DOT standards, but also the
other requirements in subpart C.
O. Requirements for All Refillers
(§§ 165.65(d) and 165.70(e))
1. Final regulation. All refillers,
including those at registrant’s facilities
and those who are not part of a
registrant’s company must comply with
the following provisions regarding
repackaging a pesticide product into
refillable containers:
*(1) The establishment must be
registered with EPA as a producing
establishment as required by § 167.20 of
this chapter.
*(2) The refiller must not change the
pesticide formulation unless he has a
registration for the new formulation.
(3) The refiller must repackage a
pesticide product only into a refillable
container that is identified on the
description of acceptable containers for
that pesticide product.
(4) The refiller may repackage any
quantity of a pesticide product into a
refillable container up to the rated
capacity of the container. In addition,
there are no general limits on the size
of the refillable containers that can be
used.
(5) The refiller must have all of the
following items at the establishment
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before repackaging a pesticide product
into any refillable container for
distribution or sale:
*(A) The written contract from the
pesticide product’s registrant.
[Subparagraph A applies only to
independent refillers.]
*(B) The pesticide product’s label and
labeling.
(C) The written refilling residue
removal procedure for the pesticide
product.
(D) The written description of
acceptable containers for the pesticide
product.
(6) Before repackaging a pesticide
product into any refillable container for
distribution or sale, the refiller must
identify the pesticide product
previously contained in the refillable
container to determine whether a
residue removal procedure must be
conducted in accordance with the
cleaning requirements described in Unit
VII.Q. The refiller may identify the
previous pesticide product by referring
to the label or labeling.
(7) The refiller must inspect each
refillable container as discussed in Unit
VII.P.
(8) The refiller must clean each
refillable container, if required, as
discussed in Unit VII.Q.
*(9) The refiller must ensure that each
refillable container is properly labeled
as discussed in Unit VII.R.
(10) The refiller’s establishment must
maintain records, as discussed in Unit
VII.S.
*(11) The refiller’s establishment
must maintain records as required by 40
CFR part 169.
*(12) The refiller’s establishment
must report as required by 40 CFR part
167.
(13) Stationary pesticide containers
(that meet the specified size criteria) at
the establishments of independent
refillers must meet the standards in
§ 165.45(f). [Paragraph 13 is only
included in the regulations in
§ 165.70(e) for independent refillers.
The refillable container regulations state
that both the registrant and independent
refillers are responsible for complying
with the stationary pesticide container
requirements.]
(14) Refillers may be required to
comply with the containment standards
in subpart E. [Paragraph 14 applies only
to independent refillers.]
These requirements, except for items
5(A), 13 and 14 which apply only to
independent refillers, apply to any
refiller that repackages a product subject
to the regulations regardless of the main
business of the refiller (registrant,
retailer, etc.). Some of these conditions
(indicated by an asterisk) simply refer to
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or reinforce key requirements in existing
regulations, including 40 CFR parts 156,
167 and 169 or incorporate existing
standards of the Bulk Policy (having a
copy of the registrant’s contract). These
provisions are included here for the
sake of completeness and as a reference
for refillers.
In other words, the new provisions for
refillers are that each refiller:
• Must repackage a product only into
a container identified on the registrant’s
description of acceptable containers;
• May repackage any quantity of a
product into a refillable container (up to
its rated capacity) and there are no
general limits on the size of the
refillable containers;
• Must have certain documents before
repackaging;
• Must identify the product
previously in the container by its label;
• Must inspect and, if necessary,
clean the container; and
• Must maintain certain records.
EPA believes that these provisions are
good management practices that are
intended to ensure product and
container integrity. The second
provision actually removes a condition
on container size from the bulk policy.
In other words, it provides more
flexibility to registrants and refillers
than currently exists.
2. Changes. Regarding the list of
requirements for refillers, the final
regulations are very similar to the
proposed rule. However, the structure
and order of the final rule was revised
to list these requirements in one section.
EPA believes this makes the regulations
more clear, which should facilitate
compliance. The items that refer to
existing requirements in 40 CFR parts
167 and 169 were added to the list to
provide a more complete reference for
refillers. However, these statements
simply refer to existing requirements;
they don’t add new ones.
Adjustments were made to a few of
the provisions. Specifically, the
requirements in the proposed rule that
referred to the registrant’s list of
acceptable containers were changed to
refer to the registrant’s description of
acceptable containers (see items 3 and 5
above), to accommodate the changes
described in Unit VII.N. Also, the
proposed regulatory text did not
explicitly allow any size refillable
container to be used, although the
preamble discussed removing the size
limit in the Bulk Policy in some detail.
Therefore, a sentence clarifying that
there are no general limits for the size
of refillable containers was added to the
statement allowing any quantity of
pesticide (up to the container’s rated
capacity) to be repackaged. (See item 4.)
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Specific modifications made to the
inspecting, cleaning, labeling and
recordkeeping requirements and
comments on these standards are
discussed in detail in Units VII.P. VII.S.
The refillable container regulations
were modified to clarify that both
registrants and refillers are responsible
for complying with the stationary
pesticide container requirements in
§ 165.45(f). The final repackaging rule
includes this provision in the list of
requirements as a reminder for
independent refillers.
P. Inspecting Refillable Containers
(§§ 165.65(e)and 165.70(f))
1. Final regulation. Before
repackaging pesticide products into
refillable containers, refillers must
visually inspect the exterior and (if
possible) the interior of the container
and the exterior of appurtenances. The
purpose of the inspection is to
determine whether the container meets
the necessary criteria with respect to
continued container integrity, required
markings and openings (tamper-evident
devices or one-way valves). As with the
proposed regulations, inspecting the
containers is the responsibility of the
refillers, since they are the ones who are
actually handling and refilling the
containers. If any of the failure
conditions in this section are observed
during the inspection, the container
cannot be refilled unless the problems
are rectified and the associated
acceptability criterion (either
reconditioning according to DOT’s
requirements or coming into compliance
with the refillable container standards
in subpart C) is satisfied.
The container fails the inspection and
must not be refilled (unless the
applicable DOT standards for
reconditioning are met) if the integrity
of the container is compromised in any
of the following ways:
• The container shows signs of
rupture or other damage which reduces
its structural integrity. [Based on the
criterion in 49 CFR 173.28(a)]
• The container has visible pitting,
significant reduction in material
thickness, metal fatigue, damaged
threads or closures, or other significant
defects. [Based on the criterion in 49
CFR 173.28(c)(1)(iii)]
• The container has cracks, warpage,
corrosion or any other damage which
might render it unsafe for
transportation. [Based on the criterion
in 49 CFR 180.352(b)(2)(iii)]
• There is damage to the fittings,
valves, tamper-evident devices or other
appurtenances that may cause failure of
the container. [Similar to the criterion in
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49 CFR 180.352(b)(2)(ii) for service
equipment.]
If either of the following conditions
exists (or both), the container fails the
inspection and must not be refilled until
the container meets the refillable
standards specified in subpart C. The
conditions are:
• The container does not bear the
markings required by subpart C or such
markings are not legible.
• The container does not have an
intact and functioning one-way valve or
tamper-evident device on each opening
other than a vent, if required.
Note that these two conditions are
written so refillers of antimicrobial
products used in swimming pools and
related sites would not have to inspect
for a serial number (because it’s not a
marking required by subpart C for these
products) or for an intact and
functioning one-way valve or tamperevident device on each opening,
because neither is required for these
products.
2. Changes. The general obligation to
inspect refillable containers before
repackaging pesticide products into
them is the same as the proposed rule.
However, EPA made several changes to
the details of the inspection. First, we
based the conditions for failing the
inspection on conditions specified in
the DOT regulations in 49 CFR 173.28
and 180.352(b)(2). A commenter
suggested this change and EPA believes
it is an appropriate modification and is
consistent with other changes in the
regulation to refer to and adopt the DOT
standards for container design,
construction and marking. While we
don’t think the criteria in the final rule
are necessarily more stringent than
those in the proposed rule, we believe
that consistency with DOT is beneficial.
Second, the inspection requirement was
modified to clarify that if problems
found during the inspection are fixed
and certain criteria are met, the
container can be refilled. Under the
proposed standard, it was not clear that
a container could be reconditioned or
brought into compliance with the
refillable container standards and then
refilled. Several other minor
modifications were made to account for
changes in the regulations, including:
(1) removing the reference to a standard
for the age of the container and (2)
clarifying that vents do not need to have
one-way valves or tamper-evident
devices. Because the refillable container
regulations in subpart C exempt
antimicrobial products used in
swimming pools and related sites from
the serial number requirement and the
standard requiring a one-way valve or
tamper-evident device, the final rule
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was written so that refillers of these
products are not subject to the failure
criteria that address serial numbers,
one-way valves, or tamper-evident
devices.
Q. Cleaning Refillable Containers
(§§ 165.65(f) - (g) and 165.70(g) - (h))
1. Final regulation. Refillers must
clean refillable containers by
conducting the pesticide product’s
refilling residue removal procedure
before repackaging the product into the
refillable container, unless condition #1
and either condition #2 or #3 are
satisfied:
(1) Each tamper-evident device and
one-way valve is intact (if required).
(2) The refillable container is being
refilled with the same pesticide product.
(3) Both of the following conditions
are satisfied.
(A) The container previously held a
pesticide product with a single active
ingredient and is being used to
repackage a pesticide product with the
same single active ingredient.
(B) There is no change that would
cause the composition of the product
being repackaged to differ from the
composition described in its
confidential statement of formula that is
required under FIFRA section 3.
Examples of unallowable changes
include the active ingredient
concentration increasing or decreasing
beyond the limits established by the
confidential statement of formula or a
reaction or interaction between the
pesticide product being repackaged and
the residue remaining in the container.
If a tamper-evident device or one-way
valve is not intact, the refiller must
clean the container according to the
product’s refilling residue removal
procedure. In addition, the final
regulations state in § 165.65(g) for
registrants who refill and in § 165.70(h)
for independent refillers that other
procedures may be necessary in this
case to assure that product integrity is
maintained.
The first condition is written so it
would not apply to refillers of
antimicrobial products used in
swimming pools because neither a oneway valve or tamper-evident device is
required.
2. Changes. The biggest change from
the proposed regulations is adding the
condition where the container is being
refilled with the same pesticide product
as a case for not needing to clean the
container. Some commenters pointed
out that the conditions in the proposed
regulation and the 1991 amendment to
the Bulk Pesticides Enforcement Policy
(Ref. 71) would require a refillable
container holding a product with
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multiple active ingredients to be
cleaned even when it was refilled with
that product. This is true because the
proposed rule, based on the 1991
amendment to the Bulk Policy, specified
a product with a single active ingredient
in a compatible formulation as an
acceptable condition for refilling
without cleaning. EPA corrected this
oversight in the final rule, because
refilling with the same product
(regardless of how many active
ingredients there are) is certainly the
most clear way to ensure product
integrity and should be allowed
(assuming any tamper-evident devices
and one-way valves are intact).
Several other minor changes include:
(1) Changing the first condition so it
includes one-way valves and not just
tamper-evident devices like in the
proposal;
(2) Adding ‘‘if required’’ to the first
condition, since one-way valves or
tamper-evident devices are only
required on portable pesticide
containers for liquids and are not
required on the containers of
antimicrobial products used in
swimming pools;
(3) Using the phrase ‘‘described in its
confidential statement of formula that is
required under FIFRA section 3’’
because it is more straightforward than
the proposed phrase as described in
Unit VII.H.;
(4) The condition in criterion 3(B) was
modified to be more general to account
for situations other than reactions or
interactions between the two products
such as very different active ingredient
concentrations that could cause the
repackaged product to differ from the
confidential statement of formula; and
(5) Splitting the situation of a broken
tamper-evident device or one-way valve
into a separate paragraph for clarity.
R. Labeling Refillable Containers
(§§ 165.65(h) and 165.70(i))
1. Final regulation. Before distributing
or selling a pesticide product in
refillable containers, refillers must
ensure that the label of the product is
securely attached to the refillable
containers such that the label can
reasonably be expected to remain
affixed during the foreseeable
conditions and period of use. The label
and labeling must comply in all respects
with the requirements of 40 CFR part
156. In particular, refillers must ensure
that the net contents statement and EPA
establishment number appear on the
label. This part of the regulations simply
re-states requirements from 40 CFR part
156 and FIFRA for clarity.
2. Changes. The major change to the
labeling requirement was to change it
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from an ‘‘active’’ standard (i.e., the
refiller must securely attach the label) to
a ‘‘passive’’ standard (i.e., the refiller
must ensure that the label is securely
attached). Also, the regulatory text was
modified to state that the net contents
and EPA establishment number appear
on the label (rather than the new label
as proposed). Both of these changes
account for situations where the label is
embossed on the container or the
container already has an intact label that
meets all the requirements. For
example, a commenter said that 1–
gallon refillable containers for the
swimming pool market are embossed
with label information because they are
refilled automatically at a rate of 100–
120 bottles per minute.
S. Recordkeeping (§§ 165.65(i),
165.67(h), 165.70(j))
1. Final regulation. All of the
companies subject to the repackaging
standards must keep certain records,
although the specific records vary
according to who the company is and
what it does. These records must be
furnished and made available for
inspection and copying upon request of
EPA or our designee, such as a State or
Tribe. Informational records (listed in
the first few rows of Table 16) must be
maintained for the current operating
year and for 3 years after that. The
47387
repackaging records (listed in the last
three rows of Table 16) must be
generated each time a product is
repackaged into a refillable container for
distribution or sale and must be
maintained for at least 3 years after the
date of repackaging. All of the records
are product-specific. In other words,
this information must be kept for each
product distributed or sold in refillable
containers. The same cleaning
procedure or description of containers
can be used for different products, but
there must be a record documenting a
procedure and a description for each
product distributed or sold in
refillables.
TABLE 16.—RECORDKEEPING REQUIREMENTS IN THE REPACKAGING REGULATIONS
Registrants who d/s directly in refillables1
Product-Specific Record
Swim pool products2
Registrants who d/s to
refillers for repackaging into refillables 1
All other products
All products
Refillers who aren’t registrants
Swim pool products2
All other products
Informational Records
Contract to repackage
No
No
Yes
Yes
Yes
Refilling residue removal procedure
Yes
Yes
Yes
Yes
Yes
Description of acceptable
containers
Yes
Yes
Yes
Yes
Yes
Repackaging Records
EPA registration number of
the product distributed or
sold in the container
No
Yes
No
No
Yes
Date of the repackaging
No
Yes
No
No
Yes
Serial number of the container
No
Yes
No
No
Yes
1 ‘‘d/s’’=
distributed or sold.
pool products = antimicrobial products used in swimming pools and closely related sites, that are subject to the pesticide container-related regulations.
jlentini on PROD1PC65 with RULES2
2 Swim
EPA reminds registrants and refillers
that the records identified in
§§ 165.65(i), 165.6(h) and 165.70(j) of
the repackaging regulations do not
change other recordkeeping
requirements that currently apply to
them, such as restricted use product
records or applicable records required
in 40 CFR parts 167 and 169.
2. Changes. EPA made the following
significant changes in the recordkeeping
requirements in the final regulations:
• The informational records must be
kept for the current operating year and
for 3 years after that rather than the
proposed time period of as long as the
pesticide product is distributed or sold
in refillable containers and for 3 years
thereafter. The specific informational
records kept by each of the three
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categories of businesses is the same in
the final rule as in the proposal,
although the list of acceptable
containers was changed to the
description of acceptable containers.
• The repackaging records in the final
rule are a subset of what was included
in the proposed rule. The final
regulations do not include the name or
quantity of the product, the name and
address of the consignee, a record that
the refiller has inspected the container
(and the results), and a record of
whether a refilling residue removal
procedure was conducted (and, if not,
why not). Additionally, the date of the
distribution or sale (in the proposal) was
changed to the date of the repackaging
in the final rule.
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• Refillers that repackage
antimicrobial products used only in
swimming pools or closely related sites
would not have to comply with the
repackaging recordkeeping. However,
these refillers would have to comply
with the informational recordkeeping.
• The proposed regulations would
have required refillers to maintain
certain records of containers that were
received by them to be refilled,
including the name and address of the
person providing the container, its serial
number, the date it was received and the
name and EPA registration number of
the product that was last distributed or
sold in the refillable container. These
records are not being finalized in
today’s final regulations.
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3. Comments - refiller records. Many
commenters (registrants, registrant
groups, State regulatory agencies, a
dealer, a dealer group, and an
equipment manufacturer) opposed the
recordkeeping requirements for refillers.
Most of these respondents commented
that the proposed recordkeeping
requirements were too burdensome and
several stated that these standards will
discourage the use of refillable
containers. A registrant group
recommended requiring refillers to
maintain records of the serial number,
the amount of product placed in the
container and the date the refilling took
place.
4. EPA response - refiller records. EPA
modified the refiller recordkeeping
requirements to minimize the
paperwork burden of maintaining these
records. However, EPA believes that
some records are necessary to ensure
safe repackaging and compliance with
these requirements. First, the refiller
must have the informational records,
including the registrant’s contract (if
applicable), the refilling residue
removal procedure and the description
of acceptable containers. These records
are necessary so the refiller has the
information needed to properly
repackage a product into refillable
containers and to ensure that an
independent refiller has the proper
approval from a registrant to repackage
the product.
Second, certain information about
when a product is repackaged into a
refillable container is needed in case
there is a problem with a product sold
in refillable containers, i.e., it is
adulterated or contaminated or it causes
damage to the site after application.
However, EPA pared the repackaging
records down to the minimum amount
of information that would allow the
refiller and investigators to identify the
product, the container, and the date of
the repackaging. All of this information
is readily available at the time the
pesticide product is repackaged into the
refillable container, unlike in the
proposed rule where the information
also included the name and address of
the person receiving the container. EPA
deleted the requirement to record the
results of the inspection and whether
the container was cleaned because these
records would probably not be useful in
enforcement cases. We will be able to
determine that a container was not
inspected if a container in poor
condition (that did not just sustain
recent damage) is found and, similarly,
we’ll be able to tell if a container was
not properly cleaned if we find high
levels of contamination in the product
in that refillable container.
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5. Comments - sodium hypochlorite.
Several respondents from the sodium
hypochlorite industry commented on
the proposed rule and stated that the
refiller recordkeeping requirements
would be especially burdensome for this
market. One registrant group described
a typical sodium hypochlorite delivery,
where a truck holding up to 4,000, 1–
gallon refillable containers stops at
several locations, delivers various
volumes of product, and picks up empty
containers. This commenter estimated
all the recordkeeping standards could
triple the time for deliveries and
increase the cost of the product by 100
percent. An association representing
many businesses involved with
swimming pools commented that the
requirement for individual serial
numbers and the recordkeeping
requirements attendant to the serial
number marking would be completely
unworkable for refillable pool chemical
containers. These respondents and a
swimming pool supply company stated
that the recordkeeping would
discourage the use of refillables in the
pool chemical industry.
When commenting on the
supplemental notice, the registrant
group representing the sodium
hypochlorite industry reiterated its
estimate of the increase in time and
costs that could be attributed to the
proposed recordkeeping. In addition, a
sodium hypochlorite manufacturer
requested EPA to exempt all refillable
plastic containers of sodium
hypochlorite from the requirements for
serial numbers, one-way valves, tamperevident devices and burdensome
recordkeeping that would negatively
impact the currently used refillable
container system.
6. EPA response - sodium
hypochlorite. EPA was persuaded by the
arguments from the companies who
repackage sodium hypochlorite into
refillable containers for use in
swimming pools. Because of the huge
number of small (1– and 2.5–gallon)
refillable containers used in this market
segment, EPA acknowledges that
compliance with this recordkeeping
would be burdensome. Therefore, the
final rule exempts refillers of
antimicrobials used in swimming pools
and similar sites from the repackaging
recordkeeping, although they must
comply with the informational
recordkeeping.
T. Proposed Standards That Are Not
Being Finalized
Final regulation/changes. The
following proposed requirements
relating to repackaging are not being
finalized in today’s final rule:
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• § 165.134(f): Age of plastic liquid
minibulk containers; and
• § 165.136(b): Records on the return
of refillable containers to refillers.
The proposed rule would have
prohibited a refiller from repackaging a
product into a plastic liquid minibulk
container more than 6 years after the
container’s date of manufacture. EPA
decided not to finalize this provision to
be consistent with the DOT regulations,
which do not establish a life limit for
plastic nonbulk containers (which may
be portable pesticide containers under
our regulations) or for plastic
intermediate bulk containers (which
also may be portable pesticide
containers under our regulations).
As discussed in Unit VII.S., EPA is
not finalizing the requirement for
refillers to keep records on the return of
refillable containers to minimize the
burden on refillers. Also, this
information would have been of limited
use because it would not have been
sufficient to conclusively identify where
a container had been and who had had
possession of it.
VIII. Containment
A. Introduction
1. Regulatory background. In 1994,
EPA proposed standards in subpart H of
40 CFR part 165 for containment of large
pesticide containers and procedures for
container refilling operations. Standards
for pesticide containers, including large
storage containers, are covered in Units
III. through VII. of this notice, and apply
to all pesticides unless specifically
exempted. The requirements for a
secondary containment unit (either a
containment structure around a
stationary container, or a containment
pad under a container refilling
operation) only apply to agricultural
pesticides. The requirements are
intended to protect human health and
the environment from contamination by
spills and leaks which may occur during
container filling or when a stationary
container fails. Affected facilities are
required to have structures which
intercept and contain spills and leaks of
agricultural pesticides in areas where
stationary containers are stored and
agricultural containers are refilled or
cleaned.
Secondary containment means a
structure, such as rigid diking, berms or
walls, designed to intercept and contain
leaks and spills from the enclosed
containers. Some States define bulk
quantities as a pesticide container with
a volume exceeding 55 gallons; others
use 210, 300, or 500 gallon criteria.
EPA’s proposed definition of bulk
quantities was 3,000 liters (793 gallons)
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for liquid pesticides and 2,000
kilograms (4,409 pounds) for dry
pesticides. The final rule establishes
quantities of 500 gallons (1,890 liters)
for liquids and 4,000 pounds (1,818
kilograms) as the threshold for requiring
secondary containment. Thus, EPA’s
regulations cover only relatively large
containers which pose the greatest risk
of catastrophic contamination in case of
failure.
EPA believes the Federal containment
standards, together with requirements
for container design and residue
removal, are essential for ensuring the
safe use, reuse and refill of containers as
required by FIFRA section 19. The
regulations promulgated today will be
located in 40 CFR part 165 in § §165.80
- 165.97.
2. Summary of proposed and final
containment standards. The proposed
and final standards include criteria for
design, maintenance and operation of
containment structures (units and pads)
at certain facilities. The design criteria
include standards for material of
construction, capacity, and protection
from stormwater and precipitation. The
facilities subject to the requirements are
agricultural pesticide refilling
establishments and custom blenders (as
defined in § 167.3), and facilities of
businesses that apply agricultural
pesticides for compensation (also
referred to as for-hire applicators in this
preamble). In the preamble to the
proposal, the Agency explained its
rationale for choosing these facilities.
Although spills can occur throughout
the chain of pesticide commerce (from
manufacturer to user), the accumulated
evidence points to agrichemical
dealerships, custom blenders, and forhire applicators as facilities where
pesticide contamination of soil and
water is most frequently documented.
(See 59 FR 6750 (Ref. 66) and Unit
VIII.C. for a detailed discussion.) The
agricultural chemical distribution
system has the most potential for spills
and a requirement for reporting spills,
and is uniquely characterized by the use
of large tanks and container refilling
operations, often outdoors, while other
sectors generally use smaller containers,
pre-packaged indoors by a
manufacturer.
Standards which are considered
critical are required for all existing and
new containment units and pads, and
some additional criteria are imposed for
new containment structures. For this
final rule, the criteria identified as
critical reflect the comments received
and new information, and are not
necessarily the same criteria used in the
proposed rule. For example, hydraulic
conductivity criteria were considered
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critical in the proposed rule, but, as a
result of comments we received on
hydraulic conductivity, are not being
finalized in the final rule (see
discussion in VIII.H).
Many respondents provided
comments on specific provisions of the
containment regulations. EPA has made
certain revisions to the proposed
regulations based on these comments.
The following units of the preamble
discuss the comments received on each
of the major issues raised in the
proposed rule, any differences between
the proposal and the final rule, and the
Agency’s reasons for making the
changes.
Costs and benefits of the rule have
been revised from those projected at the
time of the proposed rule. Total costs
are predicted to be less than estimated
in the proposal, due to the changes
made as a result of comments and new
information.
3. State secondary containment
regulations. At least 19 States have
already promulgated and begun
implementing their own secondary
containment regulations for bulk storage
of pesticides. The 1992 State of the
States Report (Pesticide Storage,
Disposal and Transportation, Ref. 70)
cited in the proposed rule showed the
wide variety of containment regulations
among States. There are variations in
the facilities affected, the container
volume triggering the requirement for
secondary containment, etc. The
economic assessment for the proposed
rule estimated the number of facilities
with bulk pesticide storage in each State
based on commercial, State and
government business census data. EPA
estimated that a total of 5,214
agrichemical dealers in all States and
the District of Columbia have containers
of a size defined in the proposed rule as
bulk (greater than 3,000 liters liquid or
2,000 kilograms dry). (Ref. 21) EPA has
reviewed the secondary containment
regulations in all 19 States and has
found that they are generally
comparable to or more stringent than
the requirements in today’s final rule.
These 19 States contain 81 percent
(4,220) of the agrichemical facilities
regulated by this final rule.
EPA received many comments on the
negative impact of the proposed
regulations on facilities in States with
preexisting regulations. Today’s
containment standards are intended to
introduce basic safeguards in States that
currently lack containment regulations
and to harmonize with containment
requirements in States where adequate
containment safety programs already
exist. While EPA believes a national
standard must provide baseline
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environmental protection, a mechanism
is being provided to accommodate
States that are already successfully
implementing pesticide containment
programs.
4. Key terms for understanding the
requirements of subpart E. The
following terms, defined in § 165.3 of
subpart A, are key to understanding the
containment standards in subpart E:
(1) Agricultural pesticide.
(2) Appurtenances.
(3) Container.
(4) Containment pad.
(5) Containment structure.
(6) Dry pesticide.
(7) Establishment.
(8) Facility.
(9) Owner.
(10) Operator.
(11) Pesticide compatible.
(12) Pesticide dispensing area.
(13) Refillable container.
(14) Refilling establishment.
(15) Rinsate.
(16) Secondary containment unit.
(17) Stationary pesticide container.
(18) Transport vehicle.
(19) Washwater.
i. Changes. Based on commenters’
suggestions and additional research, the
definitions of the following terms were
added to the final rule to clarify the
requirements: facility, pesticide
compatible, and rinsate.
ii. Comments. A regulatory agency in
a State with many bulk containment
facilities commented that the definition
of a stationary bulk container uses the
words ‘‘facility’’ and ‘‘establishment,’’
but only defines the latter. The State
agency advised that those trying to
avoid the costly container and
containment requirements might choose
to view this as a legal loophole, and that
the term facility should also be defined.
Several State agencies requested that
EPA clarify the phrase ‘‘resistant to
pesticide,’’ because its meaning could
be either compatible or unreactive and
could be difficult or burdensome to
enforce. Alternatives were proposed,
including ‘‘chemically compatible,’’
defined as the ability of the containment
structure materials to withstand
anticipated exposure to stored or
transferred materials without losing the
ability to provide the required
secondary containment of the same or
other materials within the containment
area.
Several State regulatory agencies
commented that their regulations
require containment of rinsate, and
recommend containment for wash
waters, because hazardous waste
violations at pesticide facilities are often
linked to problems with rinsate/wash
waters. One State agency asked if a 300–
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gallon spill mixed with 600 gallons of
cleanup water can be considered
rinsate. Another State agency has an
expanded definition of rinsate to
include recovered sedimentation,
washwater, contaminated precipitation,
or other contaminated debris.
iii. EPA response. The word facility
has been added to the list of definitions.
The Agency agrees that the phrase
pesticide compatible is clearer than
pesticide resistant and has changed the
regulation accordingly. For the purpose
of this regulation, rinsate is being
defined as the liquid (usually water)
used to rinse the interior of any
equipment or container that has come in
direct contact with any pesticide. The
Agency agrees that it is a good
management practice to place rinsate
tanks within containment and is
recommending that practice, but does
not have information on the risks of
storage of such dilute pesticides.
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B. Purpose (§ 165.80(a))
1. Final regulations. The purpose of
the containment standards is to protect
people and the environment from
exposure to agricultural pesticides from
spills and leaks, and to reduce wastes
produced during pesticide storage,
handling or refilling of pesticide
containers.
2. Changes. This is the same as the
proposed purpose in § 165.140.
C. Who Must Comply (§ 165.80(b))
1. Final regulations. You must comply
with these regulations if you are the
owner or operator of a facility that stores
pesticides in a stationary pesticide
container or conducts any of the
regulated pesticide transferring
activities and if you are a retailer, forhire applicator, or custom blender (as
defined in 40 CFR 167.3) of agricultural
pesticides.
2. Changes. This is the same approach
and scope that we proposed in
§ 165.141. The proposed regulations
included only retailers, for-hire
applicators, and custom blenders
because they are the three categories for
which EPA has accumulated the most
substantial evidence of soil and
groundwater contamination by
pesticides. The final rule maintains the
same scope. These facilities represent
only a subset of the realm of operations
where containment requirements might
be appropriate. The Agency may
consider further containment
rulemaking for other elements of the
pesticide industry if further information
indicates that such requirements are
needed. In addition, the final rule
revises the regulatory language to clarify
that the containment regulations only
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apply to agricultural pesticides. (See
Unit VII.L. for a discussion of custom
blending and custom mixing.) Also, a
description of ‘‘principal business is
retail sale’’ — more than 50% of total
annual revenue comes from retail
operations — was added to the final
regulation for clarity.
3. Comments. Many commenters
(dealer groups, dealers, State regulatory
agencies, and a distributor/registrant)
responding to both the 1994 proposal
and the 2004 reopening of the comment
period argued for a level playing field
and urged EPA to expand the scope of
the containment standards to include
manufacturing plants, distributors,
farms, and non-agricultural facilities.
Commenters argued that there are
similar potential risks of environmental
contamination at any facility that meets
the volume, time or activity criteria,
regardless of the location of the facility
or the type of pesticide, Many
commenters (State regulatory agencies, a
dealer, a dealer group, an aerial
applicator and an aerial applicator
group) stated that there are some farms
which store and handle more pesticides
than some small retailers, and that the
regulations should focus on the activity
and/or the quantity stored, not the
individual storing it.
Commenters to the 2004 Federal
Register Notice reopening the comment
period stated that there have been
changes in pesticide use patterns in the
11 years since the regulations were
proposed. They stated that equipment
technology developments in the
handling and application of bulk
agricultural chemicals have advanced
dramatically, and that these new
technologies coupled with the increase
in the number of farms with large
acreage have led to end users becoming
a dramatic growth sector of purchasers
of commercial application equipment. A
dealer association stated it had surveyed
chemical equipment dealers in Kansas
and that 20 to 25 percent of all new
large commercial application rigs and
80 percent of all used application
equipment is currently purchased by
end users, most of whom are farmers.
The commenter said that using such
equipment requires large quantities of
chemicals on site and concluded that
on-farm bulk storage is growing.
Another dealer association
commented in 2004 that by the end of
2006, 70 percent of all crop protection
products, mainly herbicides, will be offpatent, creating a marketing opportunity
for non-traditional suppliers and
chemical brokers. They noted that end
users could become direct crop
protection customers without
appropriate facilities, resulting in
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increased environmental incidents. The
association also stated that at least 58
percent of U.S. farmland is not farmed
by the landowner, countering the belief
that farmers are better stewards because
they have a vested interest in protecting
their farmland from contamination.
They commented that retailers are
professionals trained in handling
hazardous materials compared to end
users, who tend to have less knowledge
and training in safety, containment, and
cleanup procedures. A dealer stated that
some farmers have become tool shed
dealers who store bulk without
containment and repackage for
neighboring farmers. This point was
reinforced by retailers during a meeting
in 2004 following the reopening of the
comment period (Ref. 31), where the
dealer associations and individual
dealers reiterated their submitted
written comments and cited a growing
problem of cash and carry dealers who
repackage product on farms illegally
without a license.
Several commenters opposed
expanding the scope to include farmers.
In 2004, the Farm Bureau and associated
grower groups opposed any change in
the proposed scope. A registrant group
recommended that EPA work jointly
with State pesticide regulatory officials
and industry to devise a method for
obtaining reliable data on the number of
farmers storing bulk nationwide. The
Association of American Pest Control
Officials recommended that EPA not
expand the scope to farmers without
first researching the number, volumes
and other pertinent data regarding onfarm bulk practices, an assessment of
the risks of on-farm operations, and an
analysis of the costs and benefits of onfarm bulk containment.
Several commenters specifically
supported requiring non-agricultural
pesticides stored in bulk to be subject to
the rule. They state that bulk pesticide
storage presents potential hazards
regardless of use or activity, and that
risk may be even higher due to greater
population density compared to rural
agricultural settings.
EPA response. Due to the large
number of commenters in 1994 and
2004 from all sectors who supported
requiring farms to have containment for
stationary container pesticide storage,
the Agency considered the option of
expanding the scope of the rule to
include farms and other entities.
Although the Agency had solicited data
on bulk pesticide storage on farms and
at non-agricultural facilities in both the
1994 proposed rule and the 1999
supplemental notice, only anecdotal
information was received alleging an
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increase of stationary container
pesticide storage on farms. (Ref. 27)
The Agency therefore researched the
issue of whether pesticide storage on
farms is a significant problem. The
Agency contacted several commenters
to the rule for clarification and was
unable to confirm that the use of larger
spray equipment relates to increased
bulk pesticide storage or only to
fertilizer storage and application. In
cases where bulk storage of pesticide
most likely occurs on large farms, such
as with metam-sodium, it is not clear
that pesticide remains in the tank for 30
days or more. The Agency asked the
USDA to contact its sources in the
extension network, and Agency staff
contacted regulatory representatives and
dealers in several States, particularly
those with large areas under field crops.
In general, the persons contacted knew
of few, if any, farms with bulk pesticide
storage, with the definition of bulk as
500 gallon containers or greater.
USDA contacted Colorado, where less
than 1 percent of farmers potentially
store pesticides in bulk, and where
minibulks up to 660 gallons are exempt
from the requirement for containment if
they are approved by DOT or MACA.
USDA also contacted Illinois, Kansas
and Nebraska. Illinois has implemented
new regulations which require farmers
to have secondary containment if they
meet the volume criteria, so any farmers
with large tanks are taking them out of
service. They learned that Kansas has
three to six farms with bulk pesticides,
and most farmers are using 250 gallon
minibulks. Nebraska representatives
could not estimate how many farms
have bulk pesticide, but the most
commonly used containers are 85 to 250
gallon minibulks. The only State with
hard data was Indiana, which has 65
farmers with bulk storage (defined as
larger than 55 gallons), of which 31
reportedly had tanks larger than 500
gallons.
EPA has no data on the existence of
bulk storage in non-agricultural
facilities. EPA assumes that at such
facilities, pesticides are often stored
indoors, where the building itself
affords some measure of containment.
EPA is aware of some isolated mosquitocontrol facilities which may store
pesticides in large stationary tanks
during the treatment period, but does
not have any way to estimate the
existence of such facilities nationwide.
In short, EPA has not received
sufficient evidence of contamination at
manufacturing plants, distributors,
farms and non-agricultural sites to
justify regulating them. In the proposed
rule, we outlined the data available to
the Agency documenting contamination
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at agricultural retailers, refilling
establishments and commercial
applicator sites. At least 30 of the
references to the proposed rule were
State monitoring studies showing
contamination at such sites. Data
documenting widespread contamination
at other facilities were not submitted,
and have not been identified.
The consensus, even from
commenters who support expansion of
the scope to include farmers, is that onfarm bulk storage is still rare. The
Agency does not wish to regulate in
anticipation of a potential problem,
particularly since it is questionable that
such a regulation could be enforced on
an equitable basis. We recognize the
staff and resource restrictions of State
agencies, and do not wish to add to their
burden in anticipation of a problem
which may or may not occur in the
future.
The Agency recognizes that all large,
stationary tanks have the potential to
leak or burst, and considered requiring
all stationary tanks, regardless of
location, to conform to the containment
standards. However, the Agency also
believes that the volume through-put of
tanks used for retail sale or commercial
application of pesticides is higher than
that expected for individual farms,
resulting in a higher potential risk
associated with their usage. The Agency
further believes that an end-user who is
not significantly involved in resale of
product has less opportunity and
motivation to finance the purchase of
large tanks and the construction of
secondary containment.
EPA added a description of the phrase
‘‘principal business is retail sale’’ to the
final rule so § 165.180(b)(1) states that
refilling establishments who repackage
agricultural pesticides and whose
principal business is retail sale (i.e.,
more than 50% of total annual revenue
comes from retail operations) must
comply with the containment
regulations. EPA’s intent of including
the phrase principal business in the
1994 proposed rule was to distinguish
between refilling establishments whose
principal business is retail sale and
refilling establishments whose primary
function is formulation or
manufacturing of pesticides. The
description of principal business was
added to the final rule to provide
clarification on how to make this
distinction. In addition, the information
we received during the 2004 comment
period about some farmers reportedly
repackaging pesticides for sale further
supported the need to clarify the
meaning of principal business is retail
sale. For the reasons discussed in this
section, EPA decided not to apply the
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47391
final containment regulations to
farmers. We believe that adding the
clarification of principal business to the
final rule will help identify the retail
facilities that we intend to regulate with
§ 165.180(b)(1). However, EPA wants to
clarify that anyone including a farmer who is repackaging pesticides for sale or
distribution must comply with the
existing requirements in 40 CFR part
167 to register their establishments and
report their production (repackaging) to
EPA and must also keep records of
pesticide production according to 40
CFR part 169. In addition, such facilities
would be regulated as refillers under
this final rule and would have to
comply with the refiller requirements in
subpart D, Standards for Repackaging
Pesticide Products into Refillable
Containers. These facilities would have
to comply with the containment
requirements in subpart E if they
repackage agricultural pesticides and if
more than 50% of their total annual
revenue comes from retail operations.
The Agency is willing to amend the
regulation to include such sites if a
pervasive pattern of contamination or
other handling problems appear at other
sites in the future. It is recommended
that State and local agencies regulate
such facilities at the local level as
needed.
D. Compliance Dates (§ 165.80(c))
1. Final regulations. All containment
structures subject to today’s rule must
comply with all applicable containment
regulations for new and existing
structures within 3 years of today’s date.
2. Changes. The proposed rule
required new structures to comply with
the containment standards beginning 2
years after publication of the final rule.
Existing structures would have been
required to comply with interim
standards for a period of 8 years,
beginning 2 years after publication of
the final rule, and then existing
structures would have to comply with
the same standards as new structures.
The interim standards were defined as
critical to safe containment, and
considered readily implemented within
2 years. The interim period was
intended to allow existing structures
which have design or structural features
not amenable to upgrading without
major modification to phase in those
modifications over time. The final rule
has no provision for an interim period;
the final rule applies only one set of
requirements to existing structures over
their life spans. Both new and existing
structures must comply with applicable
standards beginning 3 years after
publication of the final rule.
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3. Comments. Many commenters had
objections or changes to propose on the
interim period. Several respondents
commented specifically on the length of
the interim period. A registrant thought
it should be longer and a State
regulatory agency said it should be
shortened to 5 years and be based on the
structure’s age and performance. A State
regulatory agency said that the nine
critical standards were sufficient and
that the only distinction between new
and existing facilities should be the
compliance date. A dealer opposed the
interim period because States already
have containment standards and would
have to learn two new sets of standards
above and beyond existing State rule.
Several respondents commented on the
different possibilities for an interim
period discussed in the preamble. A
State regulatory agency supported an
age-based approach of setting the
compliance date on a formula using 20
years minus the existing containment
facility’s age. Many commenters
(dealers, a dealer group and a State
regulatory agency group) opposed
setting any standards that are more
stringent than existing State standards.
A principal reason for opposition was
that interim requirements would
comprise an extra, unnecessary set of
requirements to be learned by regulators
and regulated parties, particularly in
States with containment programs in
place. It would also be costly for
existing structures to have to retrofit,
particularly in States where facilities
had already been constructed to
conform with State requirements.
Several commenters (State regulatory
agencies, a dealer, and a grower group)
recommended that EPA grandfather
existing containment facilities that are
already in compliance with State
standards. A State regulatory agency
group requested EPA to seriously
consider accepting small discrepancies
in some standards due to differences in
existing State rules and legislation. This
commenter said that national uniformity
in regulation is desirable, although
progress toward this goal should not be
at the expense of States that have
already enacted rules and statutes that
vary slightly from the proposed Federal
regulations. A dealer group suggested
that EPA set the Federal standards as a
baseline, which would allow the
proactive work of some States to stand.
Many dealers recommended that EPA
adopt the Iowa standards in lieu of
those in the proposal. A dealer said that
making States enforce standards
different from their own would cause
difficulties for enforcing agencies,
distributors, retailers and end users, and
a State regulatory agency elaborated,
stating that States with containment
requirements would have to reinitiate
their compliance efforts and would lose
credibility and trust of the regulated
community. A few State regulatory
agencies suggested adding a provision
that would use the time during the
interim period to collect data about the
adequacy of State regulations. If the
collected information indicated a State’s
requirements weren’t adequate, EPA
could justify compliance with the
Federal standards.
4. EPA response. The interim period
was intended to allow substandard
facilities sufficient time to retrofit and
come into full compliance with the
regulations and for owners to recoup the
benefits from the depreciation of their
capital investment and financially
prepare to upgrade their structure. EPA
has maintained a dialogue and
information exchange with States and
the regulated community (facilities and
their associations) since the rule was
published in 1994. EPA has decided not
to finalize the most onerous and
contentious standards from the
requirements for existing facilities, such
as a hydraulic conductivity standard,
thereby significantly reducing the effort
and expense needed to comply. EPA
believes that 33 months between the
reference date for new structures (3
months after publication) and the
compliance date (36 months after
publication) would provide a reasonable
period of time for new structures to be
planned and built in compliance with
the full requirements of subpart E. If an
existing structure does not already
comply with the standards for existing
structures, EPA believes that the
remaining modifications can be readily
implemented at existing structures
within 3 years. The proposed period of
2 years before compliance may not have
provided ample time for facilities to
meet the requirements, particularly
facilities in locales with significant
seasonal constraints on construction. In
addition, allowing 3 years as a
compliance date for both new and
existing structures will allow one year
for States with their own containment
regulations to apply for an equivalency
determination, and still avoid confusion
by retaining the same compliance date
for all facilities. EPA believes that
allowing one more year before
implementation will not have a
significant adverse impact on the
environment, particularly given the
many State regulations that are already
in effect. This is a shorter time frame
than the 5–year phase-in period allowed
for the refillable container and
repackaging regulations, but given that
most States with dealerships have
already implemented containment
regulations, the Agency considers 3
years sufficient time for facilities to
comply. The Agency is allowing 5 years
for compliance with the refillable
container standards because registrants
need to phase out existing containers
without recalling them prior to the
completion of their normal usable life.
The transition period helps distribute
costs over time and improve regulatory
compliance.
The critical standards cited in the
preamble of the proposed rule (59 FR
6765, February 11, 1994) for
implementation during the interim
period have been modified based on
comments, additional research, and
evaluation of existing State regulations.
The modified standards for existing
structures are considered crucial to safe
containment and comprise the basic
standards demonstrated to be effective
for existing structures in States with
containment regulations. The following
table compares standards in the
proposed rule to today’s final standards
for existing structures. New structures
are subject to these standards plus
additional standards representing
further protectiveness.
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TABLE 17.—COMPARISON OF STANDARDS FOR PROPOSED AND FINAL RULE
Standard in Proposed Rule for Existing Structures
Standard in Final Rule for Existing Structures
Construction with rigid materials.
Same.
NA
Use of pesticide-resistant materials.
Use of pesticide-compatible materials.
NA
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Additional Standard in Final Rule for New
Structures
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TABLE 17.—COMPARISON OF STANDARDS FOR PROPOSED AND FINAL RULE—Continued
Standard in Proposed Rule for Existing Structures
Standard in Final Rule for Existing Structures
Hydraulic conductivity no greater than 1 x 10-6
cm/sec during interim, 1 x 10-7 cm/sec after
10 years.
None. Liquid-tight.
NA
Withstand full hydrostatic head.
Same.
NA
Stormwater run-on protection for a 25-year,
24-hour storm.
Sufficient freeboard to contain precipitation
and prevent water and other liquids from
seeping into or flowing onto it.
NA
Protection of appurtenances and containers.
Same.
Appurtenances configured so leaks can be
observed.
Seal joints and cracks and repair any visible
damage.
Same.
NA
Inventory reconciliation of liquid remaining in
tank during interim only.
None.
NA
Pad capacity 1,000 gallons.
Pad capacity 750 gallons.
Sloped to liquid-tight sump.
Liquid stationary containers - unit capacity
100 percent/110 percent indoor/outdoor
minimum during interim, 110 percent/125
percent indoor/outdoor after 10 years.
Liquid stationary containers - unit capacity
100 percent indoor/outdoor minimum.
Liquid stationary - outdoor capacity 110 percent minimum.
Anchoring liquid stationary containers.
Anchoring or elevating liquid stationary containers.
NA
Prevent pesticide-containing material from escaping from containment.
Seal appurtenances, discharge outlets and
gravity drains through base or wall of containment unit, including sump. Containment
pads may drain to a watertight sump with
method of removing accumulated liquids,
such as a pump, which transfers contents
to aboveground container.
Appurtenances must be configured in such a
way that spills or leaks are easy to see.
Dry product stationary container - no capacity
requirement during interim, 100% after 10
years.
Dry product stationary container protected
from wind/rain with 6-inch berm at least 2
feet from container.
NA
Attended transfers; locked valves; cleanup by
the end of day of spill; monthly inspection.
Same.
NA
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E. Stationary Containers Included
(§ 165.81)
1. Final regulations. Stationary
pesticide containers designed to hold
undivided quantities of agricultural
pesticides equal to or greater than 500
gallons (1,890 liters) of liquid pesticide
or equal to or greater than 4,000 pounds
(1,818 kilograms) of dry pesticide are
subject to the containment regulations.
Containers of less than these volume/
weight capacities are not required to be
protected with a secondary containment
unit. The definition of stationary
pesticide container includes transport
vehicles that are fixed or remain at a
facility for at least 30 consecutive days.
A stationary pesticide container is
subject to the containment regulations
and must have a secondary containment
unit unless it satisfies any one of the
following conditions:
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• The container is empty, which
means that it has been cleared of all
pesticide that can be removed by
customary methods such as draining,
pumping, or aspirating (whether or not
residues have been removed by washing
or rinsing).
• The container holds pesticide
rinsates or wash waters and is so
labeled.
• The container holds only pesticides
which would be gaseous when released
at atmospheric temperature and
pressure.
• The container is dedicated and
labeled for non-pesticide use.
2. Changes. This is not the same
subset of stationary containers proposed
in § 165.142(a) as subject to, or exempt
from, the standards. The three
differences are that the: (1) Liquid
container size subject to the rule is 500
gallons rather than 793 gallons; (2) dry
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Additional Standard in Final Rule for New
Structures
container size subject to the rule is
4,000 pounds rather than 4,409 pounds;
and (3) period of time that a container
can remain fixed or at a single facility
in order to be considered stationary is
30 days, rather than the 14–day period
in the proposed rule.
3. Comments - holding capacity.
Many commenters (State regulatory
agencies, dealer groups, and another
government agency) urged EPA to
reduce the capacity threshold for
containers for which secondary
containment is required. Specific
alternative suggestions included: (1) 300
gallons for liquids or 100 pounds for dry
products; (2) 300 gallons for liquids or
500 pounds for dry products; (3) 500
gallons for liquids or 2,000 pounds for
dry products. A registrant group
commented in 2004 that packaging
experts believe plastic containers larger
than 330 gallons would not meet DOT
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Packing Group III standards, which they
cite as further evidence that containers
that size and larger need secondary
containment. A State agency stated that
they are already seeing a shift in
container size (below the regulatory cutoff) in order to be exempt from the
State’s containment regulations.
Another State agency suggested that
States have geographical differences and
that perhaps EPA should allow
individual States to mandate storage
limits based on their individual
situation. A dealer group and a
registrant group jointly commented that
containers with a liquid capacity of
greater than 330 gallons should be
protected by containment. There were
no commenters who thought the
container size of 793 gallons was
appropriate or that it should be larger.
4. EPA response - holding capacity liquids. The Agency recognized that the
liquid capacity proposed was
substantially greater than volume
criteria adopted by many States with
containment regulations. These States
use lower limit ‘‘bulk’’ criteria ranging
from 55 to 500 gallons to trigger
secondary containment requirements for
liquid pesticides. The reasoning for the
proposed definition (793 gallons) of
liquid bulk container was to be
consistent with the DOT definitions in
distinguishing between intermediate
bulk containers and bulk containers.
Since the final containment regulations
do not use definitions of bulk or
intermediate bulk, the DOT definitions
are irrelevant here. As discussed in Unit
VI.A., EPA is not finalizing the
definitions of minibulk and bulk
containers in the final rule. The
Agency’s intent for the secondary
containment requirement is to prevent
the most catastrophic spills, and the
larger the container, the greater the risk
of contamination. The Agency believes
contamination from failure of a 500–
gallon container would be significant,
and agrees with commenters that a 330–
gallon container is generally considered
the largest size container that can be
moved by a fork lift and can be
considered mobile. The next most
common size used in the field is 500
gallons. The Agency agrees with States
that those 500 gallon tanks should be
required to have secondary
containment, and is lowering the size
cut off to capture those tanks and
harmonize with existing regulations.
The Agency has confirmed by personal
communication with some State
regulators and extension staff (Ref. 28)
that there are few, if any, containers
between the sizes of 500 and 793
gallons, (the next most common size
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after 500 gallons is 1,000 gallons) and
expects that today’s rule will discourage
demand for container sizes in that range
in an attempt to be exempt from the
containment regulations. The Agency
confirmed that 500–gallon tanks are
common in the field, and recognizes
that the regulations may prompt some
demand for tanks slightly smaller (e.g.,
450 gallons) in order to be exempt from
the Federal requirement. There may
always be facilities which try to skirt the
law in such ways, but the Agency
intended the containment regulations to
prevent the environmental
consequences from the most
catastrophic spills. The smaller the tank
size, the less contamination will result
from leaks or spills. The Agency also
reviewed containment regulations in the
19 States which have them, and
determined that the size cut-off which
triggers the requirement for secondary
containment varies from 55 to 550
gallons, with many states selecting 300–
or 330–gallon tanks as the cut-off size.
The Agency believes that selecting a
volume cut off between 55 and 500
gallons would conflict with some State
regulations at a cost to both States and
facilities, with no measurable benefit to
the environment (Ref. 25) and has
therefore selected 500 gallons as a
realistic, practical and protective size
which triggers the need for secondary
containment.
5. EPA response - holding capacity dry pesticides. As with liquid
pesticides, the Agency’s goal in
proposing larger weight criteria for dry
pesticides, was to target containers that
pose the greatest risk of catastrophic
consequences in the event of failure.
The proposed size criterion for dry
pesticide containers was 4,409 pounds
(2,000 kilograms). There were many
comments on the size criterion for dry
pesticide containers in 1994. Those
comments objected specifically to the
proposed standard for 100 percent
containment capacity for such
containers based on the physical nature
of a dry spill. The Agency has
confirmed with the packaging industry
(Ref. 29) that dry pesticides are not
packaged in containers between the
sizes of 4,000 and 4,409 pounds.
Therefore, EPA is lowering the size of
the container for which containment is
required to 4,000 pounds (1,818
kilograms) for simplicity and clarity,
since 4,000 is an easier number to
remember for compliance and
enforcement purposes, and there is no
functional difference between 4,000 and
4,409 pounds for refillable dry bulk
containers, since neither size exists. In
addition, EPA has replaced the
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requirement for 100 percent
containment capacity for dry pesticides
with a requirement for a 6–inch berm in
the final rule.
6. Comments - 14–day residence.
Several commenters suggested
increasing the time criterion to 30 days
to account for factors beyond the control
of the facility. One commenter
questioned the associated recordkeeping
as burdensome and unclear as to what
was required. A registrant requested that
EPA exempt packaged product in
nonrefillable containers from the 14–
day time trigger because it would
burden small facilities.
7. EPA response - 14–day residence.
Although most large containers used at
commercial agrichemical facilities are
stationary, some containers are actually
vehicles (such as tank trucks) used for
prolonged storage or repeated on-site
dispensing of pesticide at one location.
In this case, the primary function of the
vessels shifts from pesticide transport to
pesticide storage or handling, and
therefore containment is required. Since
monthly inspection is required at such
facilities, EPA believes that it would be
reasonable to allow a 30–day maximum
residence time without containment
requirements, since any transport
vehicles temporarily stored would have
to be inspected by the owner or operator
within that period. The recordkeeping
required for stationary containers which
do not have secondary containment
could simply be a signature of the driver
and/or facility owner/operator on a
paper listing the driver’s arrival date.
The regulation is not intended to
impose burdensome recordkeeping. The
regulations will not affect packaged
pesticide in small quantities used by
small entities, since the quantities
required that would trigger containment
requirements are 500 gallons liquid or
4,000 pounds dry pesticide.
F. Pesticide Dispensing Areas Included
(§ 165.82)
1. Final regulations. Dispensing areas
are subject to the requirements for a
containment pad if one of the following
activities is conducted in the dispensing
area:
• Emptying, cleaning, and rinsing of
refillable containers that hold
agricultural pesticides.
• Dispensing of an agricultural
pesticide from a stationary pesticide
container of a size holding 500 gallons
or more of liquid or 4,000 pounds or
more of dry pesticide for any purpose.
• Dispensing of an agricultural
pesticide from a transport vehicle to fill
a refillable container.
• Dispensing of an agricultural
pesticide from any other container for
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the purpose of refilling a refillable
container for sale or distribution.
A dispensing area is exempt from
subpart E requirements for a
containment pad if it satisfies any of the
following conditions:
(1) The only pesticides handled in the
pesticide dispensing area are pesticides
which would be gaseous if released at
atmospheric temperature and pressure.
(2) The only pesticide containers
refilled within the pesticide dispensing
area are stationary pesticide containers
protected by a secondary containment
unit that complies with the
requirements of this subpart.
(3) The pesticide dispensing area is
used solely for dispensing pesticide
from a rail car that is not a stationary
pesticide container. However, if a rail
car is used as a stationary pesticide
container, secondary containment is
required.
2. Changes. This is the same approach
and scope that was proposed in
§ 165.142(b) for including and
exempting pesticide dispensing areas
from the requirement for a containment
pad. The language in § 165.82(a)(2) has
been slightly revised to reflect the lower
container sizes, and all of the conditions
have been slightly revised to be clearer.
3. Comments. As with the scope of
facilities subject to the containment
requirements above, many commenters
responding to both the 1994 proposal
and the 2004 Notice (State regulatory
agencies, a few dealer groups and a
registrant) urged EPA to expand the
scope to all permanent areas where the
transfer of pesticides from any container
occurs, regardless of container size or
pesticide type. In particular, they argued
for requiring containment pads for
mixer/loader activities by farmers or forhire applicators, citing significant soil
and groundwater contamination in
agricultural States, and equivalent risk
whenever large quantities of pesticides
are handled. They noted the possibility
that farmers are less well-trained in
pesticide management than commercial
dealers. State agencies supported
including farmer mixer/loader pads in
order to strengthen their own
regulations.
Arguments by State regulatory
agencies, user groups, a registrant, and
a registrant group against including
farmers in the scope cited the difficulty
of monitoring numerous individual
farms and lower quantities of pesticides
used. Two user groups opposed
including farmers because the costs
would be significant to farmers and
could not be passed on; the costs of
monitoring the large number of farm
sites would be burdensome; and farm
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sites generally handle less material,
which should result in fewer spills.
4. EPA response. As discussed above
in Unit VIII.C., Who Must Comply, EPA
focused on commercial agrichemical
facilities because these have the clearest
pattern of soil and ground water
contamination by pesticides. EPA did
not include farms because farms
conduct operations on an occasional
basis and would not have the same
environmental impacts as refilling
establishments. Containment on a farm
would also be expensive and require
year-round maintenance but only be
needed on a seasonal basis. EPA does
not have a good estimate of the number
of farms with stationary bulk storage,
nor evidence that significant
contamination is occurring at farm sites.
Although it follows logically that any
area where pesticides are transferred
between containers and application
equipment may become contaminated,
the quantities transferred at dealer and
commercial sites for sale to multiple
customers are expected to far exceed
quantities transferred at individual
farms.
EPA noted that the language in
§ 165.82(a)(4) did not fit the plainEnglish standard for simplicity and
revised it to clarify that the activity of
refilling refillable containers for sale or
distribution, even if the source
container is smaller than the size
requiring secondary containment,
requires a secondary containment pad.
For example, refilling a 15–gallon
minibulk from a 400–gallon stationary
tank would still require a containment
pad if the product was intended to be
sold or distributed.
G. Definition of New and Existing
Structures (§ 165.83)
1. Final regulations. A new
containment structure is one whose
installation begins more than 3 months
after the final rule is published.
Installation is considered to have begun
if:
(1) You, as the owner or operator,
have obtained all Federal, State, and
local approvals or permits necessary to
begin physical construction of the
containment structure; AND
(2) You have either begun a
continuous on-site physical
construction or installation program OR
you have entered into contractual
obligations for physical construction of
the containment structure. The contract
must be such that it cannot be canceled
or modified without substantial loss,
and must be for the physical
construction or installation of the
containment structure within a specific
and reasonable time frame.
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An existing containment structure is
one whose installation began on or
before the date 3 months after the final
rule is published.
2. Changes. This is identical to the
definitions of new and existing
containment structures proposed in
§ 165.144. However, the general
structure of the final rule is different
from the proposal, as explained in more
detail in Unit VIII.K. The proposed rule
would have required existing structures
to comply with interim standards for a
period of 8 years, beginning 2 years after
publication of the final rule, and then
existing structures would have had to
comply with the same standards as new
structures. Instead, the final rule
establishes critical design standards for
both new and existing structures, and
several additional standards for new
structures. In other words, certain
standards in the final rule apply to all
existing structures for their lifetimes.
Similar but slightly different standards
apply to all new containment structures.
As noted earlier, these standards would
not apply in States that show that their
regulations afford environmental
protection at least equivalent to that
provided by EPA’s regulations.
Also, EPA reorganized the regulatory
text so all the design and capacity
standards for new structures are
grouped together in § 165.85. (See Unit
VIII.H.) All the design and capacity
standards for existing structures are
grouped together in § 165.87. (See Unit
VIII.I.) The regulations that follow these
two groupings of standards, including
but not limited to operational,
inspection, maintenance and
recordkeeping requirements, apply to
both new and existing structures. EPA
believes this format is clearer and
should facilitate compliance compared
to the structure of the proposed rule,
which intermingled requirements for
the interim period and for new
structures.
H. Design and Capacity Requirements
for All New Structures (§ 165.85)
1. Construction materials for new
containment structures (§ 165.85(a))—i.
Final regulations. New containment
structures must be made of steel,
reinforced concrete or other rigid
material which will withstand the full
hydrostatic head, load and impact of
any pesticides, precipitation, other
substances, equipment and
appurtenances placed within the
structure. The construction material
must not be natural earthen material,
unfired clay, or asphalt, and must be
compatible with the stored pesticide.
ii. Changes. The proposed rule stated
that the construction material had to be
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resistant to pesticide. The final rule
states that the material must be
compatible with the pesticide. The
proposed rule also had the following
additional requirement for new
structures, which is not being finalized
in the final rule:
Each new containment structure must
have a hydraulic conductivity less than
or equal to 1 x 10-7 centimeters per
second. During the interim period, each
existing structure must have a hydraulic
conductivity standard less than or equal
to 1 x 10-6 centimeters per second.
iii. Comments - rigid structures. A few
State regulatory agencies supported
requiring rigid structures. One
recommended allowing flexible
synthetic liners in the base. A university
and a registrant supported the use of
steel structures. A few State regulatory
agencies and a containment materials
supplier supported portable rigid or
non-rigid structures.
iv. EPA response - rigid structures.
EPA does not believe that flexible,
portable, or non-rigid structures can
adequately ensure the permanent and
continuous liquid-tight containment of
large quantities of agricultural
pesticides or of areas where pesticides
are transferred and handled regularly.
Years of State experience with
secondary containment has shown that
structures of concrete, steel or other
rigid material are effective in containing
spills and leaks. Furthermore, as stated
in the proposed rule, key technical
guidance documents recommend that
rigid materials, especially reinforced
concrete, be used for structural support
in pesticide containment facilities.
Industry guidance (Ref. 11) indicates
that water-tight concrete can be
achieved with nonporous aggregate,
high-quality cement paste, proper
curing, etc., and that maintenance plays
an important role in keeping the
structure impermeable to liquids.
Although flexible, portable containment
structures may be appropriate in certain
other situations, EPA believes that
durable, rigid materials should be
required for stationary pesticide
containment at facilities covered in
today’s final rule.
v. Comments - hydraulic conductivity.
Several State regulatory agencies
supported the hydraulic conductivity
standard as proposed. Many
commenters (including State regulatory
agencies, another agency, registrants, a
registrant group, dealer groups, and a
dealer) commented that a hydraulic
conductivity standard would be difficult
to implement, generally citing a lack of
methods to verify compliance with such
a standard. Some respondents (dealers,
State regulatory agencies, registrants
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and a registrant group) commented that
there are no on-site, non-destructive
tests to verify hydraulic conductivity.
Respondents from a variety of
commenter categories opposed the
standard as too restrictive, unnecessary,
unachievable, and too costly. Some
commenters (registrants, a registrant
group, and State regulatory agencies)
pointed out that RCRA-mandated wood
preservative drip pads serve as primary
containment, whereas the proposed
regulations apply to secondary
containment, arguing that the same
standard should not apply in both cases.
A few State regulatory agencies
expressed concern that construction
modifications of existing structures to
comply with the capacity and hydraulic
conductivity standards may not be
technically feasible and could penalize
proactive States. A few State regulatory
agencies and a dealer group commented
that there is no evidence of pesticide
moving through concrete slabs or
unsatisfactory performance by existing
concrete structures, and one commenter
observed that most releases from
secondary containment are through
unsealed cracks and installed drains.
Respondents commented on the
methods needed to achieve a hydraulic
conductivity standard, such as use of
coatings, sealants, and liners. A State
regulatory agency supported the use of
sealants and coatings and a few dealer
groups acknowledged that coatings on
concrete would extend the useful life of
the structure and make it less
permeable. Many commenters expressed
concerns about the use of coatings and
sealants on containment structures, for
reasons such as: coatings can cover
cracks and problems that would not be
visible (dealer, dealer association and a
State regulatory agency); abrasion from
traffic (State regulatory agency) and
deterioration of sealants due to
ultraviolet light (registrant group and
several registrants) could prevent a
structure from maintaining compliance;
and high cost of maintenance and
replacement. Some commenters (dealer
groups, State regulatory agencies)
suggested qualitative alternative ways to
implement an impermeability standard:
liquid-tight with cracks, seams and
joints sealed; spill retention; leakproof,
coupled with permit and other
requirements; leakproof and constructed
with materials resistant to pesticides. A
State regulatory agency observed that
most releases from secondary
containment are through unsealed
cracks or installed drains.
vi. Comments - hydrostatic head. A
few State regulatory agencies argued
that a requirement for construction to
withstand full hydrostatic head would
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require dike walls to be unreasonably
thick in order to withstand a very rare
but not impossible tidal wave impact of
a large tank rupture. A dealer group
urged EPA to replace the standard with
the following language from the
Association of American Pest Control
Officials (AAPCO) model rule:
‘‘Secondary containment shall be
constructed of sufficient thickness,
density, and composition so as to
contain any discharged material...’’
vii. EPA response - hydraulic
conductivity and hydrostatic head.
Based on the comments and additional
research, EPA agrees that the proposed
hydraulic conductivity requirements
would be unnecessarily burdensome,
and that rigid walls of chemically
compatible material have been proven
effective in controlling accidental spills.
The 1 x 10-7 cm/sec standard was based
on the hydraulic conductivity
requirement found in current RCRA
requirements for wood preservative drip
pads in subpart W of 40 CFR parts 264
and 265. EPA agrees that secondary
containment structures are intended to
catch and briefly retain spills and
releases, not store them indefinitely,
and recognizes the difficulty in
verifying hydraulic conductivity. The
Agency has therefore decided not to
finalize the standards for hydraulic
conductivity. The Agency disagrees that
the requirement to withstand full
hydrostatic head is unreasonable. It is a
requirement in many State containment
regulations. The final rule was modified
slightly to delete the phrase (dynamic or
static) because that phrase adds more
confusion than clarity. However, EPA
believes that the standard of being
‘‘capable of withstanding the full
hydrostatic head, load and impact of
any pesticides, precipitation...’’ requires
the secondary containment unit to be
able to contain a catastrophic spill. EPA
believes that using industry
construction guidance on concrete
quality and reinforcement bars will
ensure that containment structure’s
integrity in the case of a catastrophic
spill of a large tank.
2. General design requirements for all
new containment structures
(§ 165.85(b))—i. Final regulations. These
are the general design requirements for
new containment structures:
(1) You must protect appurtenances
and pesticide containers against damage
from operating personnel and moving
equipment. Means of protection
include, but are not limited to, supports
to prevent sagging, flexible connections,
the use of guard rails, barriers, and
protective cages.
(2) Appurtenances, discharge outlets,
or gravity drains must not be configured
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through the base or wall of the
containment structure, except for direct
interconnections between adjacent
containment structures which meet the
requirements of this subpart.
Appurtenances must be configured in
such a way that spills or leaks are easy
to see.
(3) The containment structure must be
constructed with sufficient freeboard to
contain precipitation and prevent water
and other liquids from seeping into or
flowing onto it from adjacent land or
structures.
(4) Multiple stationary pesticide
containers may be protected within a
single secondary containment unit. The
volume of the largest container
determines the capacity requirement of
the unit.
ii. Changes. Requirements in
§ 165.85(b)(1) and (2) are identical to
those proposed in § 165.146(b).
Paragraph (4) is added to clarify a
statement in the proposed rule under
§ 165.152. The requirement in
§ 165.85(b)(3) has been changed. In the
proposed rule, the requirement was to
prevent storm water run-on from
seeping into or flowing onto it from
adjacent land or structures during a 25–
year, 24–hour rainfall event.
iii. Comments - storm protection.
Several respondents (a registrant and
two State regulatory agencies) supported
the stormwater control provision.
Several others (a dealer group and two
State regulatory agencies) suggested
alternative language, such as diverts
water, no discharge, or constructed to
prevent any surface water from moving
onto or across the structure. Several
commenters (a dealer group, a registrant
group and two State regulatory agencies)
noted that it would be difficult to
comply because (1) a watershed runoff
study would be needed; (2) the 25–year,
24–hour criterion would be difficult to
determine at different sites; (3) rainfall
varies substantially from year to year. A
few State regulatory agencies
commented that the stormwater control
standard doesn’t adequately address
precipitation and stated that the
containment capacity requirements
must be based on rainfall volume, such
as a 25–year, 24–hour rainfall event. A
few dealers recommended the example
of the Illinois pesticide containment
rule, which requires that stormwater be
diverted from containment structures.
iv. EPA response - storm protection. A
25–year, 24–hour storm is commonly
used as a benchmark for the capacity of
secondary containment structures, and
is recommended in the National
Pollution Discharge Elimination System
(NPDES) Best Management Practices
Guidance Document.(Ref. 74) EPA
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believes that, just as a 25–year, 24–hour
storm is a reasonable criterion for
stormwater retention (prevention of runoff), it would also serve as sufficient
freeboard and a reasonable standard for
prevention of stormwater seepage and
run-on from adjacent lands or
structures. Such a standard allows
flexibility for varying climatic
conditions. It is also the standard
required for certain tank systems storing
or treating hazardous waste. See, for
example, 40 CFR 265.1(e)(1)(ii) and
(e)(2)(ii). However, the Agency has
decided not to require a 25–year, 24–
hour storm criterion here in order to be
consistent with the final EPA rule on
Oil Pollution Prevention and Response:
Non-Transportation-Related Onshore
and Offshore Facilities (67 FR 47042,
Ref. 47). The Oil Prevention Rule states
that while a 25–year, 24–hour storm
event standard is appropriate for most
facilities and protective of the
environment, it may be difficult and
expensive for some facilities to secure
recent information concerning such
storm events at this time. Recent data do
not exist for all areas of the United
States, or may be costly for small
operators to secure. Should recent and
inexpensive information concerning a
25–year, 24–hour storm event become
easily accessible for every part of the
United States, we will reconsider
proposing such a standard. Instead, at
this time, we are requiring, as a few
commenters suggested, that the
containment structure have sufficient
freeboard to contain precipitation and
prevent water and other liquids from
seeping into or flowing onto it from
adjacent land or structures. Most States
with containment regulations do not use
a 25–year, 24–hour storm criterion, and
have indicated that, in their experience,
requiring a numerical capacity (110
percent) or sufficient freeboard to
accommodate local precipitation
conditions provides adequate
protection.
3. Capacity requirements for new
stationary liquid pesticide containment
units and new containment pads in
pesticide dispensing areas
(§ 165.85(c))—i. Capacity for new
stationary liquid pesticide containment
units—Final regulations. These are the
capacity requirements:
• New secondary containment units
for stationary liquid containers, if
protected from precipitation, must have
a capacity of at least 100 percent of the
volume of the largest stationary
container plus the volume displaced by
other containers and appurtenances
within the unit.
• New secondary containment units
for stationary liquid containers, if
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exposed to or unprotected from
precipitation, must have a capacity of at
least 110 percent of the volume of the
largest stationary container plus the
volume displaced by other containers
and appurtenances within the unit.
a. Changes. The proposed rule
required higher capacity of 110 percent
for units protected from precipitation
and 125 percent for units exposed to
precipitation.
b. Comments. Several State regulatory
agencies supported the proposed
standards, stating that adjusting the
standard to reflect variable rainfall
would add confusion. Many
commenters (dealers, dealer groups and
a State regulatory agency) supported
instead the standard that EPA had
proposed for the interim period for
existing structures, namely 100 percent/
110 percent capacity (indoor/outdoor).
Reasons cited included: (1) Many dikes
that meet this standard have been in
place for years with no overflows; (2)
EPA provides little or no justification
that capacity in excess of 100 percent of
the volume of the largest container is
necessary; (3) modifying a dike to add
additional capacity would be expensive;
and (4) many Midwestern States have
adopted the 100 percent/110 percent
standard from the AAPCO model rule.
c. EPA response. EPA agrees with
comments based on practical field
experience and has reduced the
volumes needed to 100 percent and 110
percent, respectively for indoor and
outdoor units. The 110 percent criterion
for storage areas without roofing adds an
extra margin of safety for retention of
precipitation. An extra 10% is not
needed indoors as long as the displaced
volume or other containers is added.
However, the Agency recognizes that,
for enforcement purposes, it may be
difficult to reconcile capacity with
climatic conditions. For example, in the
case of a 2–inch rain, capacity at a new
outdoor liquid pesticide facility could
be temporarily reduced to less than 110
percent of the largest tank if that tank
were full, and the facility would no
longer be in compliance. To avoid
disputed calculations of capacity, the
Agency recommends that facilities make
allowances for additional capacity
beyond the 110 percent required, such
as 125 percent, to build in a margin of
error.
ii. Capacity for new containment pads
in pesticide dispensing areas—i. Final
regulations. These are the capacity
requirements:
• New containment pads in pesticide
dispensing areas subject to the
regulations in this subpart which have
a pesticide container or pesticideholding equipment with a volume of
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750 gallons or greater must have a
holding capacity of at least 750 gallons.
• New containment pads in pesticide
dispensing areas subject to the
regulations in this subpart which do
NOT have a pesticide container or
pesticide-holding equipment with a
volume of at least 750 gallons must have
a holding capacity of at least 100
percent of the volume of the largest
pesticide container or pesticide-holding
equipment used on the pad.
ii. Changes. The proposal required
that pads have a minimum holding
capacity of 1,000 gallons, or, if no
equipment used on the pad exceeded
1,000 gallons, at least 100% of the
capacity of the largest container or
equipment used on the pad. Today’s
rule reduces the minimum pad holding
capacity to 750 gallons in the most
likely scenario where large (greater than
750 gallon) containers or pesticideholding equipment will be on the pad.
Additionally, the capacity requirement
refers to gravity capacity, as defined in
oral comments by Wisconsin state
regulatory officials (Ref. 46) in 2003.
The gravity capacity of a sump or
containment structure is the capacity
before any method of removing or
transferring the contained liquid by
pump or other means is employed. For
example, a facility is prohibited from
claiming a capacity of 750 gallons if the
sump or containment structure has an
actual capacity of less than 750 gallons
but is serviced by a pump which
transfers accumulated liquid into
holding tanks such that the effective
capacity would be 750 gallons. Since
achieving 750–gallon storage capacity
under those circumstances relies on the
proper and dependable functioning of a
pump as well as a continual supply of
fuel or electrical current to run the
pump, this is not an acceptable way of
achieving the required capacity because
if these conditions are not met, a spill
is more likely.
iii. Comments. Indiana state
regulators argued that the state had
spent three difficult years and had
invested considerable resources in
implementing its regulations, which
require a pad capacity of 750 gallons.
They stated that to get the cooperation
and voluntary compliance of the
impacted industries, they had to suggest
to those making the investment that
there would be no significant changes in
requirements. To reverse themselves
now, they stated, would jeopardize their
credibility. Illinois, a state with over
1,000 bulk facilities, suggested that the
pad capacity requirement should take
into account the additional volume of a
6–inch rainfall (the volume expected
from a 24–year, 25–hour storm). A few
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State regulatory agencies did not object
to EPA’s proposed pad capacity
requirements, although their State
regulations are slightly more stringent.
A State regulatory agency noted that the
difference between 750 gallon and 1,000
gallon capacity would do little to
accommodate a spill from a 3,000 gallon
delivery truck.
iv. EPA response. The Agency did not
have a technical basis for choosing the
1,000 gallon capacity in the proposed
rule, but based it on a review of
proposed and actual State containment
regulations. Based on comments and
subsequent research, we determined
that the criteria of 750 gallons used in
some States has proven adequate. We
believe that in most actual situations of
spillage on a pad, 750 gallons would be
adequate, especially since product
transfers must be attended under the
requirements of this subpart. In a
catastrophic event, neither 750 gallons
nor 1,000 gallons would be sufficient to
contain a large spill, and the added cost
of increasing capacity to 1,000 from 750
would exceed any marginal
environmental benefit. The Agency also
agrees with Wisconsin State regulators
that a 750–gallon pad may be as small
as 12 feet square, and that a top-loaded
tank may risk splashing during the
refilling process. Consequently, while
we are lowering the gallon capacity to
750 gallons of gravity capacity, we are
recommending that the pad have a
minimum size of 15 feet by 15 feet (or
225 square feet). Additionally, for new
operational pads unprotected from
precipitation, we recommend
constructing a pad with a gravity
capacity of 1,000 gallons.
4. Specific requirements for new
stationary liquid pesticide containment
units (§ 165.85(d))—i. Final regulations.
In addition to meeting the requirements
of § 165.85(a), (b) and (c), each new
stationary liquid container protected by
a secondary containment unit must
either be anchored or elevated to
prevent flotation in the event that the
secondary containment unit fills with
liquid.
ii. Changes. The proposed rule
required that the containment unit had
to allow for observation of leakage from
the base of any enclosed stationary
pesticide container. Thus, a flatbottomed container would have had to
be elevated so that leakage would be
visible. In addition, the proposed rule
required that flotation of the container,
in the event the containment filled with
liquid, be prevented by either elevating
or anchoring the container. The final
rule requires either elevation or
anchoring in response to comments that
argued that elevating containers is not
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necessary to detect leaks and may
engender risks from inadequate support
devices.
5. Specific requirements for new
containment pads in pesticide
dispensing areas (§ 165.85(e))—i. Final
regulations. In addition to meeting the
requirements for § 165.85(a), (b) and (c),
each new containment pad in a
pesticide dispensing area must:
• Be designed and constructed to
intercept leaks and spills of pesticides
which may occur in the pesticide
dispensing area.
• Have enough surface area to extend
completely beneath any container on it,
with the exception of transport vehicles
dispensing pesticide for sale or
distribution to a stationary container.
For such vehicles, the surface area of the
containment pad must accommodate at
least the portion of the vehicle where
the delivery hose or device couples to
the vehicle. This exception does not
apply to transport vehicles that are used
for prolonged storage or repeated on-site
dispensing of pesticides.
• Allow, in conjunction with its
sump, for removal and recovery of
spilled, leaked, or discharged material
and rainfall, such as by a manually
activated pump. Automatically
activated pumps which lack automatic
overflow cutoff switches for the
receiving container are prohibited.
• Have its surface sloped toward a
liquid-tight sump where liquids can be
collected for removal.
ii. Changes. These requirements are
identical to those in § 165.152(b) of the
proposed rule. The proposed rule noted
that tanker trucks are considerably
larger than containers or equipment
normally used on the containment pad,
but that such deliveries are not expected
to be frequent, and did not propose that
the pad had to be large enough to
accommodate the entire vehicle. This
exception does not apply to transport
vehicles that are used for prolonged
storage or repeated on-site dispensing of
pesticides, since the primary function of
such a vehicle would be pesticide
storage rather than transport. EPA
reasons that the full containment
requirements imposed on fixed
containers would also apply to nonfixed containers that remain at an
applicable facility for at least 30 days.
6. Specific Requirements for new
stationary dry pesticide containment
units (§ 165.85(f))—i. Final regulations.
In addition to the requirements in
§ 165.85(a) and (b), each new stationary
dry pesticide containment must meet
the following requirements:
• The stationary dry pesticide
containers within the containment unit
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must be protected from wind and
precipitation.
• Stationary dry pesticide containers
must be placed on pallets or a raised
concrete platform to prevent the
accumulation of water in or under the
pesticide.
• The stationary dry pesticide
container storage area must be enclosed
by a curb that is a minimum of a 6
inches high and that extends at least 2
feet beyond the perimeter of the
container.
ii. Changes. The proposal required
that dry bulk secondary containment
units have a capacity of 100 percent of
the largest container plus the volume
displaced by other containers and
appurtenances within the containment.
The Agency was concerned that dry
pesticide could still mix with rainwater,
fire suppression water, etc., to reach and
contaminate groundwater and soil. The
proposed rule did not have any
provisions for protection from wind and
precipitation, nor for elevated storage to
prevent water accumulation under the
pesticide, but did request comment on
such options. The final rule does not
have a numerical capacity requirement.
iii. Comments. Several commenters
(State regulatory agencies and a dealer
group) opposed the 100 percent
proposed capacity as excessive, since
dry materials do not spread and
disperse like liquid materials. Several
State regulatory agencies suggested that
dry bulk secondary containment should
be protected by roofing or similar cover
from wind and precipitation, which
would make 100 percent capacity
unnecessary. One State noted that it
already has dry bulk containment
regulations which require that the
containers be raised off the floor, and
several States require at least a 6–inch
curb around an area extending at least
2 feet beyond the perimeter of the bulk
tank. A registrant stated that the typical
practice is to store dry pesticides under
a roof. Some commenters offered
alternative strategies, generally based on
existing State regulations, including a
curb 6 inches high at least 2 to 3 feet
beyond the perimeter.
iv. EPA response. EPA has reviewed
State bulk storage regulations and best
management practices for storing dry
bulk pesticides and has noted that
States require storage under a roof and,
if outdoors, on pallets or raised concrete
platforms, and that the most common
requirement for dry bulk is a 6–inch
berm at least 2 to 3 feet from the
container. (Ref. 34) Given that the States
with the most experience with dry bulk
storage have the most practical
experience with dry spill containment,
EPA agrees with the common sense
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arguments of commenters regarding
protection from precipitation, elevation,
and the flow properties of dry material,
and has changed the dry containment
requirement accordingly. In regard to
roofing, EPA believes that the
advantages of keeping rainwater out of
containment will outweigh the cost of
installing a roof. However, in arid
regions, a roof may not be cost-effective,
and if EPA provided roofing
specifications, it is possible that they
would conflict with local construction
requirements and building codes.
Therefore, the final rule requires
protection from wind and precipitation
rather than specifically requiring a roof
to allow some flexibility. The Agency
agrees that 100 percent capacity, given
that dry materials spread differently that
liquids, would be excessive. We also
recognize that significant quantities of
dust may be generated during the
refilling process, where the dry product
is a dust, granules or flowable
formulation. While today’s rule makes
no requirement for dust minimization or
collection, we recommend that every
effort be made to contain the dust
generated, both for the respiratory
protection of the persons attending the
transfer and for the preservation of air
and soil quality in the vicinity of the
facility.
I. Design and Capacity Requirements for
Existing Structures (§ 165.87)
1. Construction Materials for all
existing containment structures
(§ 165.87(a))—i. Final regulations.
Existing containment structures must be
made of steel, reinforced concrete or
other rigid material which will
withstand the full hydrostatic head,
load and impact of any pesticides,
precipitation, other substances,
equipment and appurtenances placed
within the structure. The construction
material must not be natural earthen
material, unfired clay, or asphalt, and
must be compatible with the stored
pesticide.
ii. Changes. The requirements in
§ 165.87(a) for existing structures are
identical to the requirements for
construction materials for new
containment structures in § 165.85(a).
The proposed rule stated that the
construction material had to be resistant
to pesticide, while the final rule
requires the material to be compatible
with the stored pesticides. In addition,
the following proposed standard for
existing structures is not being finalized:
During the interim period, each
existing structure must have a hydraulic
conductivity standard less than or equal
to 1 x 10-6 centimeters per second. After
the interim period, each new
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containment structure must meet the
hydraulic conductivity standard for new
structures of less than or equal to 1 x
10-7 centimeters per second.
iii. Comments. General comments and
EPA’s response on construction material
are discussed in Unit VIII.H.1. EPA
believes that existing structures should
easily meet these requirements based on
the information we have gathered. We
are not aware of secondary containment
units being constructed of any of the
prohibited materials. We are aware of
the existence of some asphalt
containment pads, but we believe these
are mostly used by aerial applicators
that probably are not subject to these
regulations because they do not have
large stationary pesticide containers.
2. General design requirements for all
existing containment structures
(§ 165.87(b))—i. Final regulations. These
are the general design requirements for
existing containment structures:
(1) Protect appurtenances and
pesticide containers against damage
from operating personnel and moving
equipment. Means of protection
include, but are not limited to, supports
to prevent sagging, flexible connections,
the use of guard rails, barriers, and
protective cages.
(2) Seal (permanently close) all
appurtenances, discharge outlets and
gravity drains through the base or wall
of the containment structure, except for
direct interconnections between
adjacent containment structures which
meet the requirements of this subpart.
(3) Construct the containment
structure with sufficient freeboard to
contain precipitation and prevent water
and other liquids from seeping into or
flowing onto it from adjacent land or
structures.
(4) Multiple stationary pesticide
containers may be protected within a
single secondary containment unit.
ii. Changes. Requirements are similar
to those proposed in proposed
§ 165.146, except that (4) is added to
clarify a statement in the proposed rule
under § 165.152. The requirement in
paragraph (2) was proposed for existing
structures 10 years after the publication
date of the rule (at the expiration of an
interim period that was proposed for
existing units. See discussion on
compliance dates in Unit VIII.D. above.)
In addition, at the end of the interim
period, existing structures had to meet
the requirements for new structures,
including configuring appurtenances in
such a way that leaks and spills could
be readily observed. The final rule
requires facilities with existing
structures to seal appurtenances,
discharge outlets and gravity drains at
the base and walls. EPA believes it is
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necessary for existing structures to
comply with this requirement because
some studies cited in the proposed rule
estimated that 30 percent of the reported
pesticide spill incidents resulted from
appurtenance failure, and many releases
were reported from discharge outlets
and gravity drains. Requirements in
paragraph (3) have also been changed.
In the proposed rule, the requirement
was to prevent storm water run-on from
seeping into or flowing onto it from
adjacent land or structures during a 25–
year, 24–hour rainfall event. The
requirement has been changed to
ensuring sufficient freeboard to prevent
run-on. The comments on general
design requirements and EPA’s
responses are discussed in Unit VIII.H.2.
3. Capacity requirements for existing
stationary liquid pesticide containment
units and existing containment pads in
pesticide dispensing areas
(§ 165.87(c))—i. Capacity for existing
stationary liquid pesticide containment
units—a. Final regulations. Each
existing stationary liquid pesticide
containment unit must have a capacity
of at least 100 percent of the volume of
the largest stationary pesticide container
plus the volume displaced by other
containers and appurtenances within
the unit.
b. Changes. The proposed rule
required a capacity of 100 percent for
existing liquid bulk containment units
protected from precipitation and 110
percent for units exposed to
precipitation for the 8–year interim
compliance period. At the expiration of
the interim period, the capacity
requirements would be the same as
those proposed for new structures, that
is, 110 percent for units protected from
precipitation and 125 percent for
outdoor, unprotected units. The
approach of having an interim period is
not being finalized. The final rule
requires existing liquid pesticide
containment units to have capacities of
100 percent whether protected from
precipitation or not.
c. Comments. The comments on
capacity requirements for new and
existing stationary liquid pesticide
containment units are discussed in the
comment section under Unit VIII.H.3.a.
In addition, many commenters noted
that changes in capacity requirements
for existing structures would require
major modification, re-certification by
an engineer and significant costs. A few
State regulatory agencies noted that
little if any additional benefit will be
afforded by requiring extra capacity, and
that they had never experienced a
breach of containment structure based
on existing laws.
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d. EPA response. As discussed in Unit
VIII.H.3., EPA agrees, based on field
experience, that the proposed capacity
requirements were excessive and has
reduced the capacity requirements in
the final rule. In addition, the Agency is
not requiring a numerical standard of
110 percent for existing unprotected
units (in contrast to the requirements for
new unprotected units) in order to
harmonize with existing State
containment regulations which have
chosen to require unprotected units to
have 100 percent capacity plus either a
6–inch freeboard or capacity to
withstand a 25–year/24–hour storm.
The Agency understands that some
existing units would need to retrofit to
meet a 110 percent capacity
requirement, and that the burden of
adding the extra capacity appears to
outweigh any benefit of the extra
capacity. The Agency recognizes that
States may have existing structures in
low-precipitation areas, and is allowing
them the flexibility to define capacity
requirements above 100 percent
according to local conditions.
ii. Capacity for Existing containment
pads in pesticide dispensing areas— a.
Final regulations. Existing containment
pads with pesticide-holding equipment
with a volume of 750 gallons or greater
must have a holding capacity of at least
750 gallons. Pads which do not have a
pesticide container or pesticide-holding
equipment with a volume of at least 750
gallons must have a holding capacity of
at least 100 percent of the volume of the
largest pesticide container or pesticideholding equipment used on the pad.
b. Changes. The proposal required
that existing pads have a minimum
holding capacity of 1,000 gallons or 100
percent of the capacity of the largest
container or equipment used on the pad.
The final rule reduces the minimum pad
holding capacity to 750 gallons in the
most likely scenario where large (greater
than 750 gallon) containers or pesticideholding equipment will be on the pad.
Comments and EPA responses apply as
discussed in Unit VIII.H.3. for new
containment pads.
4. Specific design requirements for
existing stationary liquid pesticide
containment units (§ 165.87(d))—i.
Final regulations. In addition to the
requirements in § 165.87(a), (b) and (c),
each existing stationary liquid pesticide
container protected by a secondary
containment unit must be adequately
elevated or anchored to prevent
flotation in the event that the secondary
containment unit fills with liquid.
ii. Changes. This requirement is
identical to that proposed in
§ 165.148(b)(2). In the proposed rule,
existing secondary containment units
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would have had to allow for the
observation of leakage from the base of
all stationary bulk containers after the
interim period expired. As explained in
Unit VIII.H.4., the standard for
observing leakage from the base of
stationary bulk containers is not being
finalized.
5. Specific design requirements for
existing containment pads in pesticide
dispensing areas (§ 165.87(e))—i. Final
regulations. In addition to meeting the
requirements for § 165.87(a), (b) and (c),
each existing containment pad in a
pesticide dispensing area must:
• Be designed and constructed to
intercept leaks and spills of pesticides
which may occur in the pesticide
dispensing area.
• Have enough surface area to extend
completely beneath any container on it,
with the exception of transport vehicles
dispensing pesticide for sale or
distribution to a stationary container.
For such vehicles, the surface area of the
containment pad must accommodate at
least the portion of the vehicle where
the delivery hose or device couples to
the vehicle. This exception does not
apply to transport vehicles that are used
for prolonged storage or repeated on-site
dispensing of pesticides.
• Allow, in conjunction with its
sump, for removal and recovery of
spilled, leaked, or discharged material
and rainfall, such as by a manually
activated pump. Automaticallyactivated pumps which lack automatic
overflow cutoff switches for the
receiving container are prohibited.
ii. Changes. The requirements in the
final rule are identical to those in the
proposal. The proposed rule noted that
tanker trucks are considerably larger
than containers or equipment normally
used on the containment pad, but that
such deliveries are not expected to be
frequent, and did not propose that the
pad had to be large enough to
accommodate the entire vehicle. This
exception does not apply to transport
vehicles that are used for prolonged
storage or repeated on-site dispensing of
pesticides, since the primary function of
such a vehicle would be pesticide
storage rather than transport. In
addition, the proposed rule required
that, at the expiration of the interim
period, each existing containment pad
would be sloped to a liquid-tight sump
where liquids can be collected for
removal. The interim period has been
deleted, and the requirement for sloped
pads is not being finalized for existing
containment pads. The requirement for
sloped pads applies only to new
containment pads in the final rule.
6. Specific design requirements for
existing stationary dry pesticide
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containment units (§ 165.87(f))—i. Final
regulations. In addition to the
requirements in § 165.87(a) and (b), each
existing dry stationary pesticide
containment must meet the following
requirements:
• The containment must protect
stationary dry pesticide containers
within it from wind and precipitation.
• Dry stationary pesticide containers
must be stored on pallets or a raised
concrete platform to prevent the
accumulation of water in or under the
pesticide.
• The container storage area must be
enclosed by a minimum of a 6–inch
high curb that extends at least 2 feet
beyond the perimeter of the container.
ii. Changes. The proposal required
that dry bulk secondary containment
units have a capacity of 100 percent of
the largest container plus the volume
displaced by other containers and
appurtenances within the containment.
The proposed rule did not have any
provisions for protection from wind and
precipitation, nor for elevated storage to
prevent water accumulation under the
pesticide. The final rule does not have
a numerical capacity requirement. All
modifications must now be made within
3 years instead of the 10 years in the
proposed rule, but the requirements are
modified and simplified such that the
Agency believes they are feasible within
the 3–year period. See Unit VIII.H.6. for
a summary of the significant comments
and EPA’s responses.
J. Operational, Inspection and
Maintenance Requirements (§ 165.90)
1. Operating procedures for all new
and existing pesticide containment
structures (§ 165.90(a))—i. Final
regulations. An owner or operator of a
new or existing pesticide containment
structure must:
• Manage the structure in a manner
that prevents pesticides or materials
containing pesticides from escaping
from the containment structure
(including, but not limited to, pesticide
residues washed off the containment
structure by rainfall or cleaning liquids
used within the structure.)
• Ensure that pesticide spills and
leaks on or in any containment structure
are collected and recovered in a manner
that ensures protection of human health
and the environment (including surface
water and ground water) and maximum
practicable recovery of the pesticide
spilled or leaked. Cleanup must occur
no later than the end of each day on
which pesticides have been spilled or
leaked.
• Ensure that all materials resulting
from spills and leaks and any materials
containing pesticide residue are
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managed according to label instructions
and applicable Federal, State and local
laws and regulations.
• Ensure that transfers of pesticides
between containers, or between
containers and transport vehicles are
attended at all times.
• Ensure that each lockable valve on
a stationary pesticide container, if it is
required by § 165.45(f), is closed and
locked whenever the facility is
unattended.
ii. Changes. These requirements are
substantially the same as those
proposed in § 165.146(c). The order of
the standards and several minor
wording modifications were made to
improve the clarity of the requirements.
2. Inspection and maintenance of all
new and existing pesticide containment
structures (§ 165.90(b))—i. Final
regulations. The owner or operator of
each pesticide containment structure
must:
• Inspect each stationary pesticide
container and its appurtenances at least
monthly during periods when pesticides
are being stored or dispensed on the
containment structure. Your inspection
must look for visible signs of wetting,
discoloration, blistering, bulging,
corrosion, cracks or other signs of
damage or leakage.
• Immediately repair any areas
showing visible signs of damage and
seal any cracks and gaps in the
containment structure or appurtenances
with material compatible with the
pesticide being stored or dispensed.
• Not store any pesticide on a
containment structure if the structure
fails to meet the requirements of this
subpart until suitable repairs have been
made. Prompt removal of pesticides,
including emptying of stationary
containers, in order to effect repairs or
recovery of spilled material is
acceptable.
ii. Changes. These inspection and
maintenance requirements are
substantially the same as those
proposed in § 165.146(d). A few minor
modifications were made to improve the
clarity of the language. In addition,
several changes were made to be
consistent with other changes in the
regulations. In particular, EPA decided
not to finalize the hydraulic
conductivity standard, so the
corresponding inspection and
maintenance requirement is also not
being finalized. Also, the final rule
specifies that the containment structure
be compatible with the pesticides,
rather than resistant as proposed. The
corresponding inspection and
maintenance standard was changed
accordingly.
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K. Combined Pads and Units (§ 165.92)
1. Final Regulation. Facility owners
and operators may combine
containment pads and secondary
containment units as an integrated
system provided the requirements set
out in this subpart for pads and units in
§§ 165.85(a) and (b), 165.87(a) and (b)
and 165.190, and as applicable,
§§ 165.85(c)-(f) and 165.87(c)-(f) are
satisfied separately.
2. Changes. This provision for
allowing integrated containment
systems is substantially the same as that
proposed in § 165.153.
L. Recordkeeping (§ 165.95)
1. Final regulations. Facility owners
and operators subject to the
requirements of this rule must maintain
the following records, and must furnish
these records for inspection and copying
upon request by any employee of EPA
or any entity designated by EPA, such
as a State, another political subdivision
or a Tribe:
• Records of inspection and
maintenance for each containment
structure and for each stationary
pesticide container and its
appurtenances must be kept for 3 years
and must include the following
information:
• name of the person conducting the
inspection or maintenance;
• date the inspection or maintenance
was conducted;
• conditions noted;
• specific maintenance performed.
• Records for any non-stationary
container designed to hold undivided
quantities of agricultural pesticides
equal to or greater than 500 gallons
(1,890 liters) of liquid pesticide or equal
to or greater than 4,000 pounds (1,818
kilograms) of dry pesticide that holds
pesticide but is not protected by a
secondary containment unit meeting
today’s regulations must be kept for 3
years. Records on these non-stationary
pesticide containers must include the
time period that the container remains
at the same location.
• Records of the construction date of
the containment structure must be kept
for as long as the pesticide containment
structure is in use, and for 3 years
afterwards.
2. Changes. The proposed rule
required additional recordkeeping of
inventory reconciliation for existing
bulk liquid containers that were not
elevated during the interim period. The
proposed rule also required owners and
operators to maintain records of written
confirmation of hydraulic conductivity
and statements of resistance to pesticide
for as long as the structure was in use,
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and for 3 years thereafter. These
requirements are not being finalized, so
the corresponding recordkeeping
requirements are also not being
finalized. Since the standards differ
depending on whether the facility was
considered existing or new at the time
of this final rule, a new recordkeeping
requirement has been added: each
facility must maintain records of the
construction date of the containment
structure for as long as the pesticide
containment structure is in use, and for
3 years afterwards.
M. States With Existing Containment
Programs (§ 165.97)
1. Final regulations. States that have
promulgated containment regulations
effective prior to August 16, 2006, and
which also have primary enforcement
responsibility and/or certification
programs, have the option of continuing
to implement their own programs in
lieu of today’s Federal regulations under
certain conditions.
A State that wishes to continue
implementing the State’s containment
regulations must request the authority to
do so by August 16, 2007 in the
following manner:
• The State must submit a letter and
any supporting documentation to EPA.
Supporting documentation must
demonstrate that the State’s program is
providing environmental protection
equivalent to that expected to be
provided by the Federal regulations in
40 CFR subpart E.
• The State must identify any
significant changes to State regulations
which would be necessary in order to
provide environmental protection
equivalent to the EPA regulations, and
develop an estimated timetable to effect
these changes. The letter must be signed
by the designated State Lead Agency
(SLA).
EPA’s Office of Pesticide Programs
(OPP), in collaboration with the EPA
Regions and other EPA offices, will
review the State’s correspondence and
determine whether the State’s program
is adequate to provide environmental
protection equivalent to or more
protective than these Federal
regulations for new and existing
containment structures. OPP will inform
the State of its determination through a
letter authorizing or declining to
authorize the State to continue
implementing its containment
regulations and will detail any reasons
for declining authorization.
Any State that has received
authorization to continue implementing
its State containment regulations must
inform EPA by letter signed by the
designated State Lead Agency within 6
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months of any revision to the State
containment regulations. EPA will
inform the State by letter if it
determines that the State’s containment
regulations are no longer adequate based
on the revisions. The State containment
regulations will remain in effect, unless
and until EPA sends the State a letter
making this determination.
2. Changes. The proposed rule made
no provision for States to implement
their own containment regulations in
lieu of EPA’s rule.
3. Comments. Many commenters to
the 1994 proposed rule (dealers, a dealer
group, a State regulatory agency group
and individual State regulatory
agencies) opposed setting any Federal
standards that are more stringent than
existing State requirements. They
requested that EPA accept current State
rules and statutes where the
discrepancies are not significant from
Federal standards. The State regulatory
agency group requested EPA to
seriously consider accepting small
discrepancies in some standards due to
differences in existing State legislation,
and said that while national uniformity
in regulation is desirable, it should not
be at the expense of States that have
already enacted rules that vary slightly
from the Federal rule. A dealer group
suggested that EPA set the Federal
standards as a baseline, which would
allow the proactive work of some States
to stand and would preclude dealers
from incurring the same economic
burdens twice (i.e., to build and then
rebuild containment structures).
Several commenters (State regulatory
agencies, a dealer, and a grower group)
recommended that EPA grandfather
existing containment facilities that are
in compliance with State standards or
that are comparable in function, design,
and construction. Similarly, a grower
group said that State rules for bulk
containment should take precedence
over this proposal. A State regulatory
agency elaborated on these difficulties,
stating that States with containment
requirements would have to reinitiate
their compliance efforts and would lose
credibility and the trust of the regulated
industry, with whom they worked
closely to develop and implement the
State rules.
A dealer commented that forcing
States to enforce different rules from
their own would cause difficulties for
the enforcing agency, distributors,
retailers and end users who will have to
learn an extra set of requirements. A few
State regulatory agencies commented
that millions of dollars have been spent
by industry on compliance with State
regulations, some of which have been in
place since 1985, and that containment
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structures have not had failures when
built to State standards. They
recommended that the final rule be
crafted to harmonize with State or other
environmental statutes, and that it
should not penalize States which have
spent years building effective
relationships with the regulated
community for safe pesticide handling.
Similarly, many commenters to the
2004 Notice reiterated these arguments
and said States have taken a pro-active
role and have enacted pesticide
containment regulations which have
proven to be protective of the
environment and which EPA should
accept by a grandfather clause. A few
commenters in 2004 pointed out that in
some States it is not the State lead
pesticide regulatory agency (usually,
department of agriculture) that has
authority for regulating the storage of
hazardous materials/pesticides, but
instead the State environmental
protection or pollution control agency.
They argued that situations where one
State agency does the comprehensive
pesticide regulatory work but another is
charged with the containment
regulations begs questions about
responsibilities for and resources
necessary to accomplish expected
compliance monitoring and
enforcement response.
4. EPA response. The Agency agrees
that Federal regulations should
reinforce, rather than undermine or
conflict with the efforts of proactive
States. While the Agency believes in the
need for national standards, EPA does
not want to burden proactive States and
facilities in those States with additional
expenditures to revise their regulatory
implementation system if the
differences between their containment
regulations and today’s rule are
minimal, and especially where State
standards are more stringent than
Federal standards. EPA has evaluated
the pesticide containment regulations in
those States that have promulgated
them, and believes that the regulations
in those States have generally brought
facilities into compliance with today’s
regulations, with some potential
deficiencies in certain States. EPA
recognizes that simply reading
regulations without awareness of the
field reality, State enforcement
discretion, and policy and guidance
directives provided to inspectors may
provide a less accurate reading of the
equivalency of regulations.
Consequently, EPA expects that States
will be able to readily document their
equivalency by providing existing
information or pre-existing documents.
EPA does not anticipate a significant
paperwork burden for States, and is
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offering this opportunity in response to
States’ requests in comments to be
allowed to continue to implement their
own regulations. EPA believes that in
States where the lead pesticide agency
is not responsible for enforcing
containment regulations, collaboration
between the State’s agencies will be
feasible. State regulators are encouraged
to consult with EPA prior to preparing
their submission.
IX. Labeling Requirements for
Pesticides and Devices
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A. Overview
1. Final regulations. Today’s final rule
changes the requirements for labeling
pesticides in 40 CFR part 156 in several
ways. First, these regulations add a new
subpart H, entitled Container Labeling
to part 156. The new container labeling
regulations include the following
requirements:
• A statement identifying the
container as nonrefillable or refillable is
required on all pesticide labels. In
addition, nonrefillable container labels
must include several statements
providing basic instructions for
managing the container and a batch
code for the product. (See Units IX.B. IX.D. for more details.)
• Cleaning instructions for some
nonrefillable containers, specifically for
dilutable products that are sold or
distributed in rigid containers and that
are not household/residential. (See
Units IX.E. - IX.K. for more details.)
• Instructions for cleaning all
refillable containers before disposal.
(See Units IX.E. and IX.L. for more
details.)
In addition, today’s final rule
modifies several existing requirements
in 40 CFR 156.10 to allow for blank
spaces on the labels of some refillable
containers for the net contents and EPA
establishment number. In addition, the
paragraph in 40 CFR 156.10 that
requires storage and disposal statements
is being changed to be consistent with
the label requirements added to 40 CFR
part 156 in subpart H and the container
regulations being added to 40 CFR part
165 in today’s rule. (See Unit IX.M.)
Container-related labeling
instructions for plant-incorporated
protectants will be determined on a
case-by-case basis until specific labeling
guidance for plant-incorporated
protectants are promulgated under 40
CFR part 174.
Existing EPA guidance on label
statements for cleaning, recycling and
disposing of pesticide containers,
includes:
• The Label Review Manual (Ref. 44);
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• PR Notice 83–3, Label Improvement
Program — Storage and Disposal Label
Statements (Ref. 73);
• PR Notice 84–1, Clarification of
Label Improvement Program (Ref. 72);
• PR Notice 94–2, Recycling Empty
Aerosol Pesticide Containers (Ref. 65);
• PR Notice 98–10, Notifications,
Non-Notifications and Minor
Formulation Amendments (Ref. 56); and
• PR Notice 2001–6, Disposal
Instructions on Non-Antimicrobial
Residential/Household Use Pesticide
Product Labels (Ref. 49).
This guidance will be revised, if
necessary, to be consistent with the
requirements in today’s final regulation.
2. Changes. The final labeling
regulations in today’s rule cover the
same statements and topics that were
included in the proposed rule. However,
a number of changes have been made to
the regulations, including but not
limited to modifying specific
statements, adding alternative
statements, restructuring the regulations
based on the plain language format, and
exempting household/residential
pesticide products from the
requirements for cleaning instructions
on nonrefillable container labels. The
specific changes are described in the
section-by-section discussion below.
B. Identification of Container Types
(§ 156.140)
1. Final regulations. This section
applies to all pesticide products and
requires statements that, among other
things, identify the container as
nonrefillable or refillable. These
statements must be placed on the label
or container. The regulations in 40 CFR
156.10(a)(4)(i) require the label to
‘‘appear on or be securely attached to
the immediate container of the pesticide
product.’’ Therefore, the statements
required by § 156.140 cannot be placed
only on labeling that is not attached to
the container, because it may become
separated. The information may be
located on any part of the container
except the closure. If the statements are
placed on the container, they must be
durably marked on the container.
Durable marking includes, but is not
limited to etching, embossing, ink
jetting, stamping, heat stamping,
mechanically attaching a plate, molding,
or marking with durable ink.
2. Changes. In the final rule, EPA has
changed the word ‘‘permanent’’ to
‘‘durable’’ to describe the required
container marking. In addition, the
language from the preamble of the
proposed rule that lists acceptable
formats of the marking was added to the
regulations to clearly establish our
intent. Finally, the phrase ‘‘as
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47403
applicable’’ was added to the first
sentence to accommodate the fact that
the statements in paragraph (a) apply
only to labels on nonrefillable
containers and the statements in
paragraph (b) apply only to the labels on
refillable containers.
C. Statements Required for Nonrefillable
Containers (§ 156.140(a))
1. Final regulations. The final rule
requires all nonrefillable containers to
have the following four items on the
label or the container:
• The phrase ‘‘Nonrefillable
container;’’
• A statement regarding reuse;
• A statement about recycling or
reconditioning; and
• A batch code.
If the first three items are placed on
the label, they must be put under an
appropriate heading under the heading
‘‘Storage and Disposal.’’ If any of the
first three items are placed on the
container, an appropriate referral
statement, such as the statement in
§ 156.140(a), must be placed on the label
under the heading ‘‘Storage and
Disposal.’’
2. Changes. These statements were
reorganized by separating each phrase
or statement into a different regulatory
paragraph to accommodate the addition
of alternative statements. The proposed
rule included all four items, but
included the first three as one
statement: ‘‘Nonrefillable container. Do
not reuse or refill this container. Offer
for recycling if possible.’’ Also, the final
rule specifies that if the first three
statements are placed on the label
(rather than on the container), they must
be placed under the ‘‘Storage and
Disposal’’ heading on the label. EPA
added this language to reinforce the
requirement in § 156.10(i)(2)(ix) for the
instructions in subpart H to appear
under the ‘‘Storage and Disposal’’
heading. These three statements must be
under an appropriate heading under the
storage and disposal heading, although
they may be in any order. EPA believes
it is better to provide registrants
flexibility in where to place these
statements. Some registrants may
choose to place them all together, while
others may choose to place the recycling
statement after the cleaning (residue
removal) instructions.
The final rule was revised to require
a referral statement on the label if any
of the statements except the batch code
are placed on the container. Examples of
appropriate referral statements are ‘‘See
container for handling and recycling
statements.’’; ‘‘Recycling information is
located on the container.’’; and ‘‘See the
container for refill limitations.’’ The
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referral statement will provide
information to allow users who look for
refill prohibitions or recycling
statements in the storage and disposal
section of the label to find the
information.
i. Statement identifying a
nonrefillable container—Final
regulations and changes. The
identifying phrase ‘‘Nonrefillable
container’’ is identical to the identifying
phrase in the proposed regulations.
ii. Reuse Statement—Final
regulations. Registrants must choose to
use one of the following reuse
statements, as appropriate. Products
with labels that allow household/
residential use must use the statement
in item (1) or (3). All other products
must use one of the three statements.
(1) ‘‘Do not reuse or refill this
container.’’
(2) ‘‘Do not reuse this container to
hold materials other than pesticides or
dilute pesticides (rinsates). After
emptying and cleaning, it may be
allowable to temporarily hold rinsate or
other pesticide-related materials in the
container. Contact your state regulatory
agency to determine allowable practices
in your state.’’
(3) The following statement may be
used if a product is ‘‘ready-to-use’’ and
its directions for use allow a different
product (that is a similar, but
concentrated formulation) to be poured
into the container and diluted by the
end user: ‘‘Do not reuse or refill this
container unless the directions for use
allow a different (concentrated) product
to be diluted in the container.’’
iii. Changes. The proposed rule
required the first statement, ‘‘Do not
reuse or refill this container.’’ The
second statement was added to address
a common practice where pesticide
applicators use plastic jugs to hold
rinsate that contains the pesticide on the
label, which could be interpreted as a
violation of a ‘‘Do not reuse’’ statement.
While EPA has some concerns about the
widespread storage of rinsate or other
pesticide-containing materials in
pesticide containers (without proper
management practices such as marking
the contents and date on the container),
we acknowledge the day-to-day reality
of pesticide operations that sometimes
there are materials such as rinsates or
leftover tank mix that must be dealt
with. While temporarily storing these
materials in pesticide containers can
create disposal problems if the material
is not managed properly and promptly,
temporary storage is better than most of
the other low-cost, practical alternatives
such as dumping the rinsate or leftover
material. Therefore, the second
statement was added to provide some
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flexibility while still prohibiting the
reuse of nonrefillable containers for
materials other than pesticides,
including but not limited to water, food,
feed and oil. However, EPA does not
believe that household/residential
pesticide users are likely to be able to
properly manage rinsate and other
pesticide-containing materials in this
way, so this statement cannot be used
on household/residential use products.
The third statement was added in
response to comments describing readyto-use products in containers that are
intended to be sold or distributed only
once, but that can be refilled by the end
user with a concentrate (a different
product) and then diluted. The third
statement gives registrants the option to
continue distributing products in this
way, but still provides end users with
the message that these containers
should generally not be reused or
refilled.
iv. Comments - refill with concentrate.
Several commenters noted that a
prohibition on reuse or refill would
make a common practice illegal.
Specifically, some ready-to-use products
are distributed or sold in containers that
are intended to be sold or distributed
only once (and therefore meet the
definition of nonrefillable containers).
However, these containers can be
refilled by the end user (generally a
household user) with a concentrate and
then diluted. A few respondents
suggested not requiring the reuse
statement on ready-to-use product
containers and several others offered an
alternative statement for these products.
v. EPA response - refill with
concentrate. EPA agrees that the use of
containers of ready-to-use products to
be refilled with a different product (that
is a similar, but concentrated
formulation) and diluted by the end
user should be allowed to continue. In
a relatively quick search of product
labels, EPA found a number of
household/residential use herbicides
with label directions that allowed this
practice. This environmentally
beneficial practice reduces the amount
of packaging used and packaging waste
produced, since a smaller container can
be used to distribute the concentrate.
Therefore, the final regulation includes
an alternative statement that allows this
practice to continue. Currently, we
believe this situation is most commonly
used for household products, although
the final regulations were written to
allow any products (not just household/
residential use products) to be able to
use the appropriate refill/reuse
statement on their labels.
3. Recycling or reconditioning
statement—i. Final regulations.
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Registrants must use at least one of the
following statements:
(1) ‘‘Offer for recycling if available.’’
(2) ‘‘Once cleaned, some agricultural
plastic pesticide containers can be taken
to a container collection site or picked
up for recycling. To find the nearest site,
contact your chemical dealer or
manufacturer or contact [a pesticide
container recycling organization] at
[phone number] or [web site]. For
example, this statement could be ‘‘Once
cleaned, some agricultural plastic
pesticide containers can be taken to a
container collection site or picked up
for recycling. To find the nearest site,
contact your chemical dealer or
manufacturer or contact the Ag
Container Recycling Council (ACRC) at
1–877–952–2272 (toll-free) or
www.acrecycle.org.’’
(3) A recycling statement approved by
EPA and published in an EPA
document, such as a Pesticide
Registration Notice.
(4) An alternative recycling statement
that has been reviewed and approved by
EPA.
(5) ‘‘Offer for reconditioning if
appropriate.’’
ii. Changes. The final rule includes
options for container recycling
statements to account for differences in
the process for recycling different kinds
of containers (e.g., aerosol cans or
plastic jugs) and differences in recycling
among markets (agricultural or
household). In addition, the proposed
rule specified the statement ‘‘Offer for
recycling if possible.’’ In the final rule,
EPA changed the word possible to
available. Finally, EPA added a
statement ‘‘Offer for reconditioning if
appropriate’’ as an alternative.
iii. Comments - recycling. Several
commenters addressed the issue of
recycling. A user group supported the
continued development of container
collection and recycling programs. A
registrant endorsed recycling but
commented that the language must
comply with Federal Trade Commission
(FTC) guidance. A registrant group
requested that the terms of PR Notice
94–2 ‘‘Recycling Empty Aerosol
Pesticide Containers’’ as amended by
letter on June 9, 1994, be codified into
regulation. A State regulatory agency
urged EPA to specifically direct users to
agricultural pesticide container
collection programs to prevent
agricultural pesticide containers being
offered for household recycling
collection. Another State regulatory
agency suggested a label statement
requiring small rinsed containers to be
delivered to State-authorized container
collection programs. This commenter
stated that use of the word ‘‘possible’’
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would be problematic because while it
is possible for farmers to travel more
than 100 miles to a recycling center, it
would be unreasonable to expect that. A
group of people involved with pesticide
container recycling in Washington State
submitted suggestions for changing the
storage and disposal statements on
pesticide containers. These comments
specifically supported the efforts of the
Ag Container Recycling Council (ACRC)
and recommended a statement that
refers to the ACRC and provides the
ACRC web site.
In response to the 2004 notice, four
State regulatory agencies and a
registrant group urged the Agency to do
more to encourage recycling of pesticide
containers and to remove label
references to burning or burying
containers. A few State agencies noted
efforts by ACRC, Earth 911 and the
National Pesticide Stewardship Alliance
to promote recycling and reform label
language. These respondents noted that
the Agency needs to go further than
what was proposed in the rule in order
to improve labeling such that burning
and burying of containers is no longer
allowed.
iv. EPA response - recycling. EPA
agrees with intent of the commenter
who suggested codifying PR Notice 94–
2. The third option included in the final
rule, a recycling statement approved by
EPA and published in an EPA
document, is included to account for PR
Notice 94–2, other PR Notices, the label
review manual, and other documents.
EPA agrees with the State regulatory
agencies and Washington container
recycling group that it may be beneficial
to provide more specific information
about pesticide container collection and
recycling programs in this statement,
particularly for agricultural pesticide
products. Therefore, the final
regulations allow the use of a new
recycling statement that provides details
about how to obtain more information
on agricultural pesticide container
collection and recycling programs such
as the ACRC. The ACRC is a non-profit
organization that promotes and supports
the collection and recycling of plastic
pesticide containers in the U.S. The
collection and recycling programs
conducted by the ACRC grew
significantly during the 1990’s, so EPA
is adding this statement to reflect
currently available programs (that were
in the developmental stage when the
proposed regulations were being
written). For example, in 1993 the
ACRC collected about 2.5 million
pounds of plastic containers. In 2001,
ACRC collected over 7 million pounds
of plastic containers, which represents
about 25 percent of the plastic
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containers distributed by the ACRC
member companies. (Ref. 1) EPA has
been told by ACRC recyclers and
member companies and by ACRC’s State
partners that participation could be
increased if the label specifically
referred to the ACRC program. EPA
hopes to encourage the recycling of
pesticide containers by including this
recycling statement as an option. EPA
also recognizes the need for flexibility
in the label instructions, as other,
equally effective organizations may
come into existence in the future, and
that the organization Earth 911
(www.earth911.org), a clearinghouse of
information on household hazardous
waste disposal and recycling, may
eventually include information
resources specifically for managing
agricultural chemicals and containers.
EPA agrees that the word ‘‘possible’’
may not be clear, and has replaced it
with the word ‘‘available.’’ ACRC
programs are available that is, accessible
for agricultural pesticide users across
much of the U.S., but not all areas have
local collection programs. EPA believes
that a reasonable interpretation of
‘‘available’’ is that pesticide containers
are collected at a location that is the
same distance or closer than the
distance the user traveled to purchase
the pesticides. It is worth noting that the
statement ‘‘Offer for recycling if
available’’ and the other statements in
§ 156.140(a)(3) give pesticide users an
option for managing the containers.
These statements do not require the
recycling or reconditioning of
containers. EPA believes that recycling
or reconditioning pesticide containers is
a responsible, preferable way of
managing pesticide containers. We
encourage these practices to save
resources and minimize the amount of
material being disposed, although there
are other legal ways of managing the
containers.
The final rule also includes the option
for a registrant to offer an alternative
recycling statement. This is intended to
allow for the possibility of changes in
the extent to which and the manner in
which pesticide containers are recycled
over time. EPA must review and
approve an alternative recycling
statement before it can be placed on a
pesticide label. One part of our review
will involve considering whether the
alternative statement is consistent with
the FTC guidelines on environmental
statements in 16 CFR part 260, ‘‘Guides
for the Use of Environmental Marketing
Claims.’’ (Ref. 5) (http://www.ftc.gov/
bcp/conline/edcams/eande/index.html)
EPA agrees with commenters that
label language regarding burning and
burying containers needs to be
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improved and is engaged in discussions
with stakeholders to address this issue.
Container disposal instructions were not
addressed in the proposed container
and containment regulations and
therefore are outside the scope of the
final regulations. In addition, EPA staff
are actively working on improving the
label manual.
v. Comments - reconditioning. Many
commenters on the proposed
regulations, including container
manufacturer and registrant groups,
stated that the regulations do not
account for the reconditioning of
containers and opposed many proposed
provisions because they would be
problematic for reconditioning. These
respondents also commented that some
containers are commonly reconditioned,
particularly plastic and steel drums
holding non-agricultural pesticides.
vi. EPA response - reconditioning.
EPA added a statement about
reconditioning to the final rule as an
alternative for containers that are
commonly reconditioned. The statement
says ‘‘Offer for reconditioning if
appropriate’’ because reconditioning is a
logical, reasonable option only for
certain containers, specifically drums,
and not others, such as plastic jugs and
aerosol cans. EPA believes this
flexibility should alleviate some of the
commenters’ concerns about the
apparent disregard for reconditioning.
4. Batch code—i. Final regulations. A
lot number, or other code used by the
registrant or producer to identify the
batch of the pesticide product, is
required for each nonrefillable container
either on the label or the container.
ii. Changes. The text specifying a lot
number or other code in the final rule
is identical to the text in the proposal.
In the final rule, though, the
introductory paragraph was modified to
clarify that the lot number/batch code
could be placed anywhere on the label
or durably (not permanently) marked on
the container.
D. Statements Required for Refillable
Containers (§ 156.140(b))
1. Final regulations. For refillable
containers, one of the following
statements is required on the label or
the container:
(1) ‘‘Refillable Container. Refill this
container with pesticide only. Do not
reuse this container for any other
purpose.’’
(2) ‘‘Refillable Container. Refill this
container with [common chemical
name] only. Do not reuse this container
for any other purpose.’’
If the statement is on the label, it must
be placed under the ‘‘Storage and
Disposal’’ heading. If the statement is
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put on the container, the label must
include an appropriate referral
statement under the ‘‘Storage and
Disposal’’ heading.
2. Changes. The proposed rule
specified only the first statement. In
response to comments, the second
statement was added to the final rule as
an option to accommodate containers
that may be filled with a chemical that
has both pesticidal and non-pesticidal
uses. Also, the phrase ‘‘Refillable
container’’ was added to both
statements to allow pesticide users,
registrants and government regulators to
clearly identify whether a container is
nonrefillable or refillable. The final rule
specifies that if the statement is placed
on the label (rather than on the
container), it must be placed under the
‘‘Storage and Disposal’’ heading. EPA
added this language to reinforce the
requirement in § 156.10(i)(2)(ix) for the
instructions in subpart H to appear
under the ‘‘Storage and Disposal’’
heading. Lastly, the final rule was
revised to require a referral statement on
the label if the statement is placed on
the container. An example of an
appropriate referral statement is
‘‘Refilling limitations are on the
container.’’ The referral statement will
provide information to allow users who
look for refill prohibitions in the storage
and disposal section of the label to find
the information.
E. Residue Removal Instructions General (§ 156.144)
1. Final regulations. Unless exempt
from these requirements, the label of
each pesticide product must have
instructions on the removal of pesticide
residue prior to disposal, as specified in
§§ 156.146 and 156.156. The regulations
in § 156.144 include the following
specifications:
• Residue removal statements are
required for both nonrefillable and
refillable containers.
• Residue removal statements must
be placed under the heading ‘‘Storage
and Disposal.’’
• Residential/household use pesticide
products are exempt from the residue
removal statement requirements.
• EPA may modify or waive the
residue removal requirements or permit
or require alternative labeling
statements.
2. Changes. The most significant
change to this section is that the final
rule exempts residential/household use
pesticide products from the residue
removal statement requirements. The
proposed rule would have applied to
the labels of all products, regardless of
the pesticide market in which they are
sold, distributed and used. EPA also
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made a few minor changes in the final
rule. The proposed rule specified a
subheading entitled ‘‘Container
Cleaning’’ under the heading ‘‘Storage
and Disposal.’’ In the final rule, EPA
deleted this subheading because it is
unnecessary. Section 156.144(b)
regarding placement of the residue
removal statements was shortened by
deleting the reference to Directions for
Use, which isn’t necessary. EPA
believes requiring the statements to be
placed under the heading ‘‘Storage and
Disposal’’ is sufficient because
§ 156.10(i)(2)(ix) requires this heading to
be included in the directions for use.
Finally, a few editorial changes were
made to shorten the phrase ‘‘residue
removal statements and instructions’’ to
‘‘residue removal instructions’’ to be
more precise and consistent. The rest of
the requirements of § 156.144 are
identical to those in the proposed rule.
FIFRA section 19(f) mandates
‘‘regulations prescribing procedures and
standards for the removal of pesticides
from containers prior to disposal’’ and
says that EPA ‘‘may, at the discretion of
the Administrator, exempt products
intended solely for household use’’ from
these requirements. In the proposed
rule, EPA chose not to exercise this
discretion and proposed to require
cleaning instructions on the labels of
household products because the
preamble of the proposed rule stated
that, in many instances, the same
pesticide product in the same container
is sold for agricultural or industrial use,
as well as for use in the home, yard, or
garden.
The 1999 Supplemental Notice (Ref.
53) stated that the changes in scope
would only apply to the container
standards and that:
EPA believes that it is appropriate to have
container cleaning and disposal instructions
on the labels of all pesticides because of
safety and environmental protection
considerations for recycling operations. It is
necessary for pesticide containers to be
properly emptied and cleaned prior to being
recycled to protect workers who handle the
recyclable material and to prevent releases of
pesticides to the environment. Because
pesticide containers from all segments of the
pesticide industry are currently being
recycled, container cleaning and disposal
instructions are needed on the labels of all
pesticides. ...
During the development of the final
PR Notice 2001–6, ‘‘Disposal
Instructions on Non-Antimicrobial,
Residential/Household Use Pesticide
Product Labels,’’ however, EPA decided
to change this position for nonantimicrobial, residential/household use
pesticide products. (Ref. 49). As stated
in PR Notice 2001–6:
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Specific instructions to consumers to rinse
their empty containers have been left out of
these revised instructions. Experience has
shown that many consumers are confused by
rinsing procedures and often incorrectly
dispose of the rinse water down the drain or
down sewers. States have reported some
detections of pesticides in drinking water
that appear, in some cases, to be linked to
disposal or rinsing in residential waste water
systems. In addition, storage of rinsate is
highly discouraged because of the absence of
adequate labeling or packaging. There is also
the potential risk of adverse chemical
reactions occurring when products are
poured down drains, singly, or in
combination with other products.
One potential solution that EPA
considered but rejected when finalizing
PR Notice 2001–6 was to require rinsing
of non-antimicrobial, residential/
household use pesticide containers and
to include instructions on the label for
how to manage the rinse water. For
example, the label statement in PR
Notice 2001–6 could have instructed the
user to add the rinse water to the
pesticide mixture that will be applied,
or if that isn’t feasible, the rinse water
could be applied to a site on the label
in accordance with the other label
provisions. EPA rejected this option
because it could confuse consumers, it
could lead to the storage of rinse water
in the absence of adequate labeling or
packaging, and it would require several
additional sentences on an already
crowded label.
Therefore, EPA has decided to omit
rinsing instructions from the label
directions specified for nonantimicrobial, residential/household
pesticide products in PR Notice 2001–
6. In markets where empty containers of
these pesticides are recyclable, it is
assumed that the recycling programs
will provide consumers with
instructions to rinse the containers if the
recycling program believes it is
necessary. Additionally, if a
manufacturer wants to include a rinsing
statement on the labels of these
pesticides, EPA would consider such a
request. However, if a manufacturer
chooses to include a rinsing statement,
it should also include instructions about
how to manage the rinse water.
In the final rule, EPA is continuing
the policy to omit rinsing instructions
from the label directions for nonantimicrobial, residential/household
pesticide products. In addition, EPA
decided to extend this policy to
antimicrobial, residential/household
pesticide products in the final rule.
Antimicrobial products were not
included in the scope of PR Notice
2001–6 because of differences of
opinions on the disposal statements in
the PR Notice, not because of problems
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with applying the no-rinsing policy to
household/residential antimicrobial
products. EPA believes that some of the
same concerns about household/
residential pesticide users, including
users being confused and trying to
prevent the storage of rinsate, apply
equally to antimicrobial and nonantimicrobial products used by these
household/residential pesticide users.
F. Residue Removal Instructions for
Nonrefillable Containers - General
(§ 156.146)
1. Final regulations. Section 156.146
sets out the residue removal instructions
for nonrefillable containers. The label of
a product must comply with these
instructions if all of the following
criteria are met:
• The product must comply with the
residue removal instructions based on
§ 156.144 (i.e., it is not a residential/
household product, EPA has not waived
the requirement, or EPA has not
established an alternative requirement);
• The product is dilutable (it could be
a liquid or a solid); and
• The product is distributed or sold
in a nonrefillable container that is rigid.
The preamble to the proposed rule
stated that EPA was holding sections in
reserve for residue removal instructions
for other formulation/container
combinations, such as dilutable
products in non-rigid containers. While
EPA may address other kinds of
nonrefillable containers in the future,
the final rule establishes residue
removal instructions only for dilutable
products in rigid nonrefillable
containers.
The labels of dilutable products that
are subject to this requirement and that
are sold or distributed in rigid,
nonrefillable containers must comply
with the following standards:
• A statement instructing the user to
clean the container promptly after
emptying is mandatory;
• Triple rinsing instructions are
mandatory;
• Pressure rinsing instructions are
optional; and
• A registrant must obtain EPA
approval before including a rinsing
procedure that specifies a diluent other
than water.
These requirements are discussed in
more detail in Units IX.G. through IX.K.
below.
2. Changes. The final regulation
includes several changes from the
proposal. The most significant changes
are that the final rule requires
registrants to place the triple rinse
instructions on all labels and provides
registrants the option to also include the
pressure-rinse instructions. The
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proposed rule gave registrants the
option to include either triple rinsing or
pressure rinsing or both. Based on
comments, EPA changed the final rule
because triple rinsing is always
possible, whereas pressure rinsing
requires specific equipment. Other
substantial changes to the residue
removal instructions include:
• Adding the phrase ‘‘or equivalent’’
as an option so labels allow equivalent
means of rinsing containers. This was
added to account for systems (such as
closed system rinsing or home-made
pressure rinsing systems) that are
designed to clean containers thoroughly
but do not technically triple rinse the
containers. This change was made to the
statement identifying when containers
must be rinsed and is discussed in more
detail in Unit IX.G.
• Both the triple rinse and pressure
rinse procedures were modified so they
would take less time. For example, the
intervals of time for draining and
shaking the containers were reduced.
These changes are intended to make the
procedures more practical and therefore
more likely to be followed by end users.
These changes are discussed in more
detail in Unit IX.H.
Numerous other minor modifications,
which are described in Units IX.G. IX.K., were made to the residue removal
instructions for nonrefillable containers.
3. Comments - which procedure? The
proposed rule would have required the
placement of either the triple rinse or
the pressure rinse procedure on the
label, with the option of including both.
The preamble requested comments on
this approach. The following comments
addressed this question.
i. Both procedures. Several State
regulatory agencies and a registrant
group supported including both triple
and pressure rinsing instructions on
labels. A few of these commenters
pointed out that pressure rinsing alone
is not available to all applicators.
ii. Alternative approach. A few dealer
groups recommended using the
statement ‘‘Pressure rinse or triple
rinse’’ so users and dealers will not have
to worry about having both rinse
systems available.
iii. Either or both procedures. A
registrant group supported the approach
of allowing the registrant to put either
or both of the statements on the label,
because pressure rinsing would not be
appropriate for institutional products
and including both would crowd the
label.
iv. Limit pressure rinsing. Some
commenters, including registrants,
registrant groups, and a State regulatory
agency, expressed concern about
household users pressure rinsing small
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containers. Many of these respondents
suggested excluding pressure rinsing
from household product labels. A
registrant group also added institutional
and industrial products to this
suggested exclusion. Similarly, another
registrant group commented that
pressure rinsing is not common in the
institutional sector. Alternatively, a few
registrant groups and a registrant
recommended that pressure rinsing
instructions be permitted only on
containers with capacities larger than
one gallon.
v. Decision making process. Some
registrants and registrant groups
commented that EPA implies that some
sort of decision making process must be
used to determine if triple rinsing,
pressure rinsing, or both should be
included and requested EPA to clarify
this. For example, does a container have
to meet a six 9’s standard by a
laboratory pressure rinsing test for
pressure rinsing instructions to be
included on the label? If so, EPA has to
specify the pressure rinsing test
procedure.
vi. Effectiveness of procedures.
Several commenters addressed the
efficacy of pressure rinsing vs. triple
rinsing. A registrant group and two
registrants commented that pressure
rinsing should be recommended on
labels only if it has been shown to be
as effective as triple rinsing. Another
registrant stated that their studies (in
addition to the work of other
companies) shows that pressure rinsing
is not as effective as triple rinsing. A
State regulatory agency commented that
pressure rinsing is a more effective
method of cleaning containers.
vii. Advantages of pressure rinsing. A
State regulatory agency and a registrant
commented that pressure rinsing is
advantageous to the pesticide users
because it is a faster procedure.
4. EPA response - which procedure?
EPA agrees with several of the points
made by commenters, in particular, that
pressure rinsing alone is not available to
all applicators, that pressure rinsing
isn’t appropriate for certain containers
based on the pesticide market and/or
container size, and that pressure rinsing
is attractive to pesticide users because it
is a faster procedure. Therefore, EPA
changed the approach so the final
regulation requires labels to include the
triple rinse procedure and gives
registrants the option to also include the
pressure rinse procedure. This approach
provides a rinse procedure (triple
rinsing) that all pesticide users can
follow. It also gives registrants the
option to include pressure rinsing if
they believe it is appropriate (with EPA
concurrence during the review of
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labels), which is preferable to
establishing criteria for appropriate (or
inappropriate) pressure rinsing
situations in the regulations.
EPA believes that both triple rinsing
and pressure rinsing are effective ways
for users to clean most containers (with
possible exceptions for size and other
situations) in the field. This conclusion
is based on the rinsing studies described
in Reference 40 and on the field
experience of people who have
inspected containers over the past
decade of pesticide container recycling
programs. One registrant group
provided comprehensive comments
during the 2004 reopening of the
comment period based on the ACRC’s
experience over the past 10 years. This
commenter described ACRC’s efforts to
assess and control the risk from using
the recycled plastic and noted that,
since ACRC’s inception in 1992, there
have been no reports of incidents where
public health or safety has been
compromised as a result of exposure to
the minimal residues found in recycled
plastic pesticide containers. This
registrant group also stated that ACRC’s
experience with recycling clean, rinsed
one-way pesticide containers for more
than a decade leads them to believe that
residue removal is an issue of
instructing applicators to triple or
pressure rinse containers immediately
after use.
EPA’s goal is to establish a situation
where all containers are adequately
cleaned before they are recycled,
disposed, or otherwise managed. As
stated in Unit V.H.1., one regulatory
contribution to achieving this goal is
ensuring that pesticide users have
access to clear, detailed instructions for
how to clean the containers. In the final
rule, pesticide labels must include triple
rinse instructions and may also include
pressure rinse instructions.
Another regulatory contribution is to
ensure the use of container designs and
formulations that facilitate effective
residue removal, which is the intent of
the residue removal standard for
nonrefillable containers in § 165.25(f).
The residue removal test procedure
requires containers to be triple rinsed.
In this case, triple rinsing is used as an
indication of how easily the pesticide
can be removed from the container. The
residue removal test procedure does not
require containers to be pressure rinsed
nor is it intended to evaluate whether
triple rinsing or pressure rinsing is more
effective for a certain container and
pesticide formulation. Therefore, the
decision of whether or not to include
pressure rinsing instructions on the
pesticide label is not tied to the results
of laboratory residue removal testing.
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Instead, registrants have the option to
include pressure rinsing if they believe
it is appropriate (with EPA concurrence
during the review of labels).
There are other integral parts to
achieving the goal of having clean
containers before they are disposed or
recycled, including educating pesticide
users on the importance of rinsing and
the proper procedures, potential spot
checks/inspections to ensure that the
labels and regulations are being
complied with, and creating an
incentive for pesticide users to comply
(or a disincentive for non-compliance).
EPA looks forward to working with all
stakeholders, including State regulatory
agencies, pesticide registrants,
distributors and dealers, pesticide users,
pesticide educators, and trade
associations in accomplishing this goal.
G. Timing of the Residue Removal
Procedure (§ 156.146(a))
1. Final regulations. For products that
are subject to the requirements for
residue removal instructions, the label
of each nonrefillable container must
include one of the following statements:
(1) ‘‘Clean container promptly after
emptying.’’
(2) ‘‘Triple rinse or pressure rinse
container (or equivalent) promptly after
emptying.’’
(3) ‘‘Triple rinse container (or
equivalent) promptly after emptying.’’
The statement about timing must
immediately precede the rinsing
instructions and must be consistent
with the rinsing instructions (triple
rinse or both triple and pressure rinse)
that are include on the label.
2. Changes. This section of the final
rule includes three changes from the
proposed regulation. First, the proposed
requirement to rinse ‘‘immediately’’
after emptying was replaced in the final
rule by requiring the container to be
rinsed ‘‘promptly’’ after emptying it.
Second, the final rule adds the phrase
‘‘(or equivalent)’’ to the two statements
that identify a specific cleaning
procedure, e.g., triple rinsing. Third, the
proposed rule included four options for
statements to include on the label. EPA
is not finalizing one of these statements
in the final rule--‘‘Pressure rinse
container immediately after emptying’’
--because it is no longer needed. The
final rule does not allow pressure
rinsing to be the only procedure listed
on the label, so this statement is
irrelevant.
3. Comments - clean promptly. Some
State regulatory agencies supported the
statement regarding the timing of
rinsing, stating that it should improve
the management of the containers. Two
other State regulatory agencies stated
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that, based on results from their
container collection and recycling
programs in the early 1990’s, it is
obvious that not all containers are
rinsed immediately. A registrant group
suggested using the phrase ‘‘reasonably
promptly’’ rather than ‘‘immediately’’ to
account for industrial situations where
its not practical to rinse immediately
such as when multiple oil wells are
treated from the same drum of an
industrial biocide and rinsing
equipment is not available. An
agricultural pesticide registrant
supported immediate rinsing in a farm
context so that the rinsate could be
added to the application mixture, but
noted that clean water may not be
available at every loading site.
4. EPA response - clean promptly.
EPA considers the timing of the residue
removal procedure to be a critical factor
in effectiveness, and is maintaining the
approach in the proposed rule that
requires users to rinse containers within
a certain (short) time period after
emptying them. When rinsing is not
performed soon after emptying the
container, the residue can dry and
adhere to the inside and outside of the
container, and is then more difficult to
remove. Containers with dried residue
are likely to be rejected by pesticide
container recycling and collection
programs as well as at solid waste
landfills.
EPA believes that requiring pesticide
users to rinse containers promptly after
emptying them is the best approach for
the final rule. Specifying that the
containers are cleaned promptly
accomplishes the goal of rinsing them
soon after they are emptied and before
the residue dries in the containers. Also,
prompt rinsing provides a little more
flexibility than immediate rinsing. As an
example, consider a pesticide applicator
who pours product from one container,
sets it down to pour out another
container, and then rinses both
containers. Technically, this could be
considered a violation if the label
specified immediate rinsing, because
some time passed between the emptying
and the rinsing of the first container.
However, this example fits within EPA’s
understanding of prompt action.
Requiring that containers be rinsed
promptly gives pesticide users,
regulatory agencies and inspectors some
discretion in determining appropriate
time spans. It is beyond the scope of this
preamble to describe every situation
that is or is not appropriate, so EPA is
relying on the good judgement of
applicators, regulatory agencies and
inspectors to assess the specific
conditions of the situation. However,
EPA believes that situations where the
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time between emptying and rinsing is
days or weeks and where the residue
has completely dried inside the
container are definitely beyond the
boundaries of prompt rinsing. In
addition, EPA strongly recommends that
pesticide users rinse containers when
the application mixture is being
prepared so the rinsate can be added to
the application mixture. This provides
many benefits, including getting all of
the value out of the product and
avoiding the creation of a potential
waste (which could happen if the
rinsate was collected separately).
5. Comments - equivalency. In
commenting on the proposed approach
for residue removal instructions, a few
commenters (a State regulatory agency
and a registrant) supported maintaining
the current cleaning statement of
‘‘Triple rinse (or equivalent)’’ because it
is sufficient if followed and it offers
flexibility.
6. EPA response - equivalency. EPA
agrees with the commenters that
including the phrase ‘‘(or equivalent)’’
that is on current labels is beneficial and
the final rule adds this phrase as an
option to the ‘‘rinse promptly’’
statement. This phrase was added to
account for systems (such as closed
system rinsing or home-made pressure
rinsing systems) that are designed to
clean containers thoroughly but do not
technically triple rinse the containers.
The alternative rinsing system should be
thorough and it is the responsibility of
the pesticide user to ensure that it is
equivalent to triple rinsing.
H. Duration of Triple and Pressure
Rinse Procedures (§ 156.146(b) and
156.146(c))
1. Final regulations. As discussed in
Unit IX.I. for triple rinsing and Unit IX.J.
for pressure rinsing, the rinsing
procedures for containers that are small
enough to shake that are defined in the
final regulation take less time to
conduct than the proposed procedures.
The key time intervals identified in the
procedures are:
• How long to drain liquid product
from containers (both triple and
pressure rinsing);
• How long to agitate/shake
containers during triple rinsing;
• How long to drain rinsate from
containers after each shaking interval
during triple rinsing; and
• How long to pressure rinse the
container during pressure rinsing.
2. Changes. The procedures in the
final rule specify the following times for
each of these intervals for containers
that are small enough to shake:
• 10 seconds to drain liquid product
from containers for both triple and
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pressure rinsing (changed from 30
seconds in the proposal);
• 10 seconds to agitate/shake
containers during triple rinsing
(changed from 30 seconds in the
proposal);
• 10 seconds to drain rinsate from
containers after each shaking interval
during triple rinsing (changed from 30
seconds in the proposal); and
• At least 30 seconds to pressure
rinse the container during pressure
rinsing. (The proposed rule specified 30
seconds; the phrase ‘‘at least’’ was
added to compensate for variations in
pressure rinsing equipment and in
pressure.)
3. Comments. A registrant group, a
registrant and two State regulatory
agencies commented that a shorter rinse
time would be better and would
encourage user compliance, although
the two State regulatory agencies
supported a shorter rinse time only if it
was demonstrated that the containers
are cleaned adequately. Another State
regulatory agency stated that, in a 1991
survey, 43 percent of private applicators
and 11 percent of commercial
applicators responded that they did not
rinse containers because it took too
much time. A registrant group opposed
the initial drain time of 30 seconds as
too long and inappropriate for closed
systems. This commenter also
responded that some states have
requirements different than a 30–second
drain and urged EPA to consider these
alternatives. A registrant commented
that the times of the proposed rinsing
procedures seemed reasonable and
expressed doubts that the triple rinse
procedure could be shortened much.
This commenter added that a 40–second
pressure rinse is inadequate to achieve
99.9999 percent removal.
4. EPA response. In the preamble of
the proposed rule, EPA estimated that
the proposed triple rinsing instructions
would take approximately 5 minutes to
perform and the pressure rinsing
procedure would take approximately 2
minutes. EPA also requested comments
on the time burden of the proposed
rinsing procedures, and the voluntary
submission of data on residue removal,
including in particular the cleaning
efficiency of any suggested shorter triple
rinse and pressure rinse procedures.
EPA agrees with the commenters that
a shorter rinse time would be better and
would encourage user compliance with
the requirement to rinse pesticide
containers. In particular, we believe it is
relatively unlikely that a pesticide user
would spend about 5 minutes triple
rinsing each container. The 30–second
intervals for the initial container drain
time, the shaking time and the rinsate-
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draining times were based on the
rinsing instructions of many States,
which were incorporated into the
laboratory triple rinse test methodology
for the proposed nonrefillable container
residue removal standard.
EPA contracted for two studies on the
effectiveness of shorter triple rinse
procedures. In a study conducted by
Formulogics (Refs. 7 and 38), a flowable
concentrate product was tested in three
containers: 1–gallon and 2.5–gallon
plastic jugs and a 5–gallon steel flathead
can. Nine different rinsing procedures
were conducted for each container size
by varying the initial drain, shake and
rinsate drain times between 5, 10 and 30
seconds. The shake and rinsate drain
times were always the same. For
example, the three variations for the
initial drain time of 5 seconds were: 5
second shake and 5 second rinsate
drain; 10 second shake and 10 second
rinsate drain; and 30 second shake and
30 second rinsate drain. These same
three shake and rinsate drain times were
conducted for the initial drain times of
10 second and of 30 seconds. The
pesticide concentration in the second
through fifth rinses was measured. EPA
concludes that all nine rinsing
procedures tested were effective in
cleaning all three containers because the
active ingredient concentration in the
fourth rinse showed at least 99.99%
removal in all rinse time iterations. Two
of the rinse procedures for the 5–gallon
container (5 sec. initial drain/5 sec.
shake & rinsate drain and 30 sec. initial
drain/5 sec. shake & rinsate drain)
resulted in 99.99 percent removal; all
other rinse procedures for all containers
met at least five 9’s percent removal and
most resulted in six 9’s percent removal.
In a study conducted by the
University of Florida (Refs. 14 and 41),
two formulations were tested in three
containers, 1–gallon, 2.5–gallon and 5–
gallon plastic jugs. The flowable
concentrate was tested in all three
containers and the emulsifiable
concentrate was tested in the 2.5–gallon
and 5–gallon containers. Four different
rinsing procedures were conducted for
each container size by varying the initial
drain, shake and rinsate drain times
between 10 and 30 seconds where the
shake and rinsate drain times were
always the same. Again, EPA concludes
that all four rinsing procedures tested
were effective in cleaning both
formulations from all of the containers
because the active ingredient
concentration in the fourth rinse
showed at least 99.99% removal in all
rinse time iterations.
The triple rinse procedure for labels
in the final rule includes 10 second
initial drain, shake and rinsate drain
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times. EPA believes the data described
above shows that this shorter triple
rinsing procedure, which should
encourage end user compliance with the
requirement to triple rinse, will
adequately clean containers prior to
recycling or disposal.
In addition, EPA has lowered the
residue removal requirement in the final
nonrefillable container regulations from
six 9’s (99.9999 percent) to four 9’s
(99.99 percent), as discussed in Unit
V.H. The shorter rinse procedures
reached at least 99.99 percent removal
in all of the containers and formulations
tested. As cited by one of the State
regulatory agencies in its comments, the
field reality is that many users who do
not rinse claim the time factor as the
reason. By reducing the time frames in
the cleaning instructions, EPA hopes to
increase compliance within the
pesticide user community.
I. Triple Rinse Instructions
(§ 156.146(b))
1. Final regulations. For products that
are subject to the requirements for
residue removal instructions, the label
of each nonrefillable container must
include triple rinse instructions. There
are three different sets of triple rinsing
instructions:
• For containers that are small
enough for users to shake them, holding
dilutable liquid pesticides;
• For containers that are small
enough for users to shake them, holding
dilutable solid pesticides; and
• For containers that are too large for
users to shake.
In general, EPA believes that the largest
containers that users can shake during
a triple rinse are those with capacities
of 5 gallons for liquids and 50 pounds
for solids.
The triple rinse instructions for liquid
dilutable pesticide products in
containers small enough for users to
shake are:
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Triple rinse as follows: Empty the
remaining contents into application
equipment or a mix tank, and drain for 10
seconds after the flow begins to drip. Fill the
container 1/4 full with water and recap.
Shake for 10 seconds. Pour rinsate into
application equipment or a mix tank or store
rinsate for later use or disposal. Drain for 10
seconds after the flow begins to drip. Repeat
this procedure two more times.
The final rule specifies slightly
different instructions for solid dilutable
pesticide products in ‘‘shake-able’’
containers, because solid materials do
not ‘‘drip’’ as liquids do. The only
difference for solid dilutable pesticide
products is that the first line is ‘‘Triple
rinse as follows: Empty the remaining
contents into application equipment or
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a mix tank. Fill the container 1/4 full...’’
The rest of the procedure is identical to
the one for liquids.
For containers that are too large for
users to shake (i.e., containers larger
than 5 gallons for liquids or 50 pounds
for solids), the triple rinse instructions
are:
Triple rinse as follows: Empty remaining
contents into application equipment or a mix
tank. Fill the container 1/4 full with water.
Replace and tighten closures. Tip container
on its side and roll it back and forth, ensuring
at least one complete revolution, for 30
seconds. Stand the container on its end and
tip it back and forth several times. Turn the
container over onto its other end and tip it
back and forth several times. Empty the
rinsate into application equipment or a mix
tank or store rinsate for later use or disposal.
Repeat this procedure two more times.
2. Changes. One significant change
from the proposed rule is that the final
regulation requires a triple rinse
procedure to be on the label, where the
proposal gave registrants the option to
include triple rinsing or pressure rinsing
or both. Another modification is that the
final regulations provide a defined
procedure for containers that are too
large for users to shake. Also, the phrase
‘‘or a mix tank’’ was added as an option
for where the product or the rinsate can
be placed. In addition, the following
clarifying changes were made to both
sets of instructions for triple rinsing
smaller containers that can be shaken:
• The introductory text specifies that
the instructions apply to ‘‘containers
small enough to shake’’;
• The instruction to ‘‘agitate’’ was
changed to ‘‘shake’’; and
• As discussed in Unit IX.H., the time
intervals were changed from 30 seconds
to 10 seconds for the initial draining of
the container (for liquid products only),
the time the container needs to be
shaken, and for the draining of the
rinsate.
3. Comments - general. A State
regulatory agency pointed out that the
directions prohibit preparing the use
dilution in a mix tank, which is a
common practice. A registrant
commented that the degree of agitation
needs to be specified, e.g., shake
vigorously for 30 seconds.
4. EPA response - general. EPA did
not intend to prohibit users from
pouring a product into a mix tank or
diluting a product in a mix tank, and we
have amended the triple rinse
procedures to address this oversight.
The phrase ‘‘or a mix tank’’ was added
to the instructions for emptying
containers and to the rinsate
management instructions to allow the
product and rinsate to be placed into
application equipment or a mix tank.
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EPA agrees with the registrant and
believes that ‘‘shake’’ is a better
description of the intended activity than
‘‘agitate.’’ We decided not to include the
qualifier ‘‘vigorously’’ to keep the
statement as succinct as possible. This
kind of information could be passed
along to users during training and
outreach.
5. Comments - large containers.
Several commenters described problems
with cleaning drums according to the
proposed triple rinse statement. A
registrant group stated that it is
impractical to fill a 55–gallon drum one
quarter full because more than 40
gallons of rinsate would be produced. A
different registrant group and a
registrant recommended directing the
user to place the drum on its side and
roll it, because it is extremely difficult
to shake a large container that is onequarter full. Another registrant
commented that an additional statement
that describes rinsing by recirculation
would be helpful, but pointed out that
many drum users don’t use pumps to
empty them.
6. EPA response - large containers.
EPA agrees with the suggestion by the
commenters who recommended
directing the user to place a drum on its
side and roll it. EPA is hesitant to
recommend a cleaning procedure for
larger containers that requires
equipment that a pesticide user may not
have, such as a pump, or an
appropriately sized, heavy-duty
pressure rinse nozzle. Therefore, we
decided to define a triple rinse
procedure in the final regulation for
containers that are too large to be
shaken. This is consistent with the
approach in the final rule to require
triple rinsing because all pesticide users
can comply with these instructions and
to allow pressure rinsing as an optional,
additional statement.
J. Pressure Rinse Instructions
(§ 156.146(c))
1. Final regulations. For products that
are subject to the requirements for
residue removal instructions, the label
of each nonrefillable container may
include pressure rinse instructions. The
decision regarding whether to include
pressure rinsing instructions as an
option is at the discretion of the
registrant, based on the registrant’s
assessment of the procedure’s
effectiveness and appropriateness for
the formulation/container combination.
However, if the statement ‘‘Triple rinse
or pressure rinse container (or
equivalent) promptly after emptying’’ is
used on the label as the statement about
timing, pressure rinse instructions must
be placed on the label. If a registrant
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chooses to include pressure rinsing
instructions on the label as an option for
cleaning a liquid dilutable pesticide
product, the statement must
immediately follow the triple rinse
instructions.
The pressure rinse instructions for
liquid dilutable pesticide products are:
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Pressure rinse as follows: Empty the
remaining contents into application
equipment or a mix tank and continue to
drain for 10 seconds after the flow begins to
drip. Hold container upside down over
application equipment or mix tank or collect
rinsate for later use or disposal. Insert
pressure rinsing nozzle in the side of the
container, and rinse at about 40 PSI for at
least 30 seconds. Drain for 10 seconds after
the flow begins to drip.
Slightly different instructions are
required for pressure rinsing dilutable
liquid and dilutable solid pesticide
formulations, because dry materials do
not ‘‘drip’’ like liquids do. The pressure
rinsing procedure specified in the final
regulations for dilutable solid pesticides
is identical to the one for liquids, except
it does not include the initial 10–second
draining prior to rinsing.
2. Changes. One significant change is
that pressure rinsing instructions are
optional in the final rule, which
requires a triple rinse procedure to be
included on the labels of products that
must comply. The proposal gave
registrants the option to include triple
rinsing or pressure rinsing or both. In
addition, the following changes were
made to both sets of instructions for
pressure rinsing:
• The phrase ‘‘or a mix tank’’ was
added as an option for where the
product or the rinsate can be placed.
• As discussed in Unit IX.H., several
of the time intervals were changed from
30 seconds to 10 seconds for the initial
draining of the container (for liquid
products only) and for the draining of
the rinsate after the pressure rinse. The
length of the pressure rinse interval was
changed from ‘‘30 seconds’’ to ‘‘at least
30 seconds.’’
• Several details about the orientation
of the container were added, including
that the user must hold the container
upside down and insert the rinsing
nozzle in the side of the container.
• The pressure requirement was
changed from exactly 40 PSI to ‘‘about
40 PSI’’ to allow a range of pressures in
response to several comments
expressing concern about requiring a
pressure of exactly 40 PSI in the field.
3. Comments - container orientation.
A few commenters noted that the
instructions are not clear in stating that
the container must be inverted and that
the rinse nozzle must be inserted on the
side (or bottom) of the container. A
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registrant group suggested inserting the
nozzle ‘‘on the side of the container
opposite the closure and in a direction
towards the bottom of the container.’’ A
registrant recommended instructing the
user to ‘‘Force pressure rinsing nozzle
through what was the bottom of the
container or through the side of the
container and...’’ and also recommended
that the instructions specify holding the
container upside-down during the rinse
process.
4. EPA response - container
orientation. EPA agrees with these
commenters that more details about
how to hold the container and where
the nozzle should be inserted should be
included. Therefore, the procedure was
modified to instruct the user to hold the
container upside down and to insert the
rinsing nozzle in the side of the
container.
K. Non-Water Diluents (§ 156.146(d))
1. Final regulations. A registrant who
wishes to require users to clean a
container with a diluent other than
water (e.g. solvents) must submit a
written request to EPA to modify the
residue removal instructions of this
section. EPA may grant the request if
certain conditions are met. The
registrant must indicate why a nonwater diluent is necessary and must
propose appropriate residue removal
instructions and disposal instructions
that identify the diluent. If the nonwater diluent is permitted by the label
to be used in application, the
instructions may allow the rinsate to be
added to application equipment or mix
tank. If use of the diluent in application
is not permitted, the rinsate must be
collected and stored for eventual
disposal. EPA must approve, in writing,
the modification of the residue removal
instructions before the pesticide product
can be distributed or sold.
2. Changes. The final regulations are
almost identical to the proposed
regulations regarding non-water
diluents. The final rule adds the
requirement for the registrant to propose
disposal instructions to ensure that end
users have information about how to
appropriately dispose of rinsate from a
diluent other than water. One minor
modification was to add ‘‘or mix tank’’
as an option for where rinsate may be
added if the label allows the non-water
diluent to be part of the application
mixture. This change was made to be
consistent with the changes in the triple
rinse and pressure rinse instructions. In
addition, several minor editorial
changes were made to make this section
more clear.
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47411
L. Residue Removal Instructions for
Refillable Containers (§ 156.156)
1. General (Introductory Text for
§ 156.156)—i. Final regulations. The
label of each pesticide product packaged
in a refillable container must include
the residue removal instructions
specified in § 156.156. The residue
removal instructions must be given for
all pesticide products that are
distributed or sold in refillable
containers, including those that do not
require dilution prior to application.
ii. Changes. This requirement is
substantively the same as it was in the
proposed regulation. Some minor
editorial and format changes were made
to improve the clarity of the regulatory
text. In addition, the second sentence,
which reinforces that the instructions
apply to all products that are distributed
or sold in refillable containers,
including those that do not require
dilution prior to disposal, was moved
from the subsection on instructions for
residue removal to the introductory text.
EPA made this change because the
explanatory language applies to the
whole section (including instructions on
the timing of the procedures).
2. Timing of residue removal
procedures (§ 156.156(a))—i. Final
regulations. The label of a pesticide
product packaged in a refillable
container (and that is subject to this
requirement) must have one of the
following sets of instructions on the
timing of container cleaning:
• ‘‘Cleaning the container before final
disposal is the responsibility of the
person disposing of the container.
Cleaning before refilling is the
responsibility of the refiller.’’
• ‘‘Pressure rinsing the container
before final disposal is the
responsibility of the person disposing of
the container. Cleaning before refilling
is the responsibility of the refiller.’’
The statement must immediately
precede the residue removal
instructions and must be consistent
with those instructions.
ii. Changes. These statements were
expanded in the final regulation to
distinguish between cleaning before
disposal and cleaning before refilling in
response to comments. The proposed
statements simply said ‘‘Clean [or
pressure rinse] container before
disposal.’’ The changes in the final rule
include adding ‘‘final’’ to the
description of disposal, adding that the
person disposing of the container is
responsible for cleaning it, and
including the additional statement of
‘‘Cleaning before refilling is the
responsibility of the refiller.’’
3. Residue removal instructions prior
to container disposal (§ 156.156(b))—i.
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Final regulations. For pesticide products
sold or distributed in refillable
containers, the label must include
instructions for cleaning the container
prior to disposal. The instructions must
be appropriate for the characteristics of
the product and adequate to protect
human health and the environment. The
instructions could include any one of
the following, as long as the instructions
meet the standards described in the
previous sentence:
• The refilling residue removal
procedure developed by the registrant
for the pesticide product.
• Standard industry practices for
cleaning refillable containers.
• For pesticides that require dilution
prior to application, the following
statement:
‘‘To clean container before final
disposal, empty the remaining contents
from this container into application
equipment or a mix tank. Fill the
container about 10% full with water.
Agitate vigorously or recirculate water
with the pump for 2 minutes. Pour or
pump rinsate into application
equipment or rinsate collection system.
Repeat this rinsing procedure two more
times.’’
• Any other statement the registrant
considers appropriate.
ii. Changes. The final regulations are
almost identical to those in the
proposed rule, except for a few editorial
and format changes. The phrase ‘‘To
clean container before final disposal’’
was added to the specified procedure to
emphasize that users should only clean
the container before disposal and not
before having the container refilled. The
phrase ‘‘into application equipment or a
mix tank’’ was added to be consistent
with the emptying instructions for
nonrefillable containers. One sentence
that helps clarify the scope of the
requirement for residue removal
instructions on refillable containers was
moved from this section to the
introductory text since it applies to the
whole section.
M. Amendments to Existing § 156.10
1. Final regulations. The final rule
modifies the existing regulations in 40
CFR 156.10 in the following three ways:
• A new § 156.10(d)(7) is added that
allows the labels for refillable containers
to have a blank space to allow the net
weight or contents to be marked in by
a refiller according to 40 CFR 165.65(h)
or 165.70(i);
• The existing § 156.10(f) was
modified to allow labels for refillable
containers to have a blank space to
allow the EPA establishment number to
be marked in by a refiller according to
40 CFR 165.65(h) or 165.70(i); and
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• The existing § 156.10(i)(2)(ix)
regarding storage and disposal
instructions was modified to refer to the
applicable requirements in the rest of
today’s final rule.
2. Changes. The most significant
change to the approach taken in the
proposed regulation is that ‘‘shall’’ was
changed to ‘‘may’’ in the two paragraphs
establishing blank spaces, thus changing
them from requirements to options for
pesticide registrants. This change was
made to provide flexibility to registrants
in response to comments. EPA decided
to make several minor revisions to the
paragraphs allowing blank spaces to
link the 40 CFR part 156 regulations to
the 40 CFR part 165 repackaging
regulations and to clarify that the blank
space does not change the requirement
for having the net contents or EPA
establishment number on the label.
First, the regulatory text allowing blank
spaces was modified to refer to the 40
CFR part 165 regulations that require
refillers to ensure that the net contents
and EPA establishment number appear
on the label. Second, the new paragraph
in § 156.10(d)(7) was amended to clarify
that § 156.10(a)(1)(iii) requires the net
contents to be shown clearly and
prominently on the label.
The paragraph on storage and
disposal instructions was modified to
account for changes in the structure of
the container-related labeling, so it
refers to subpart H of part 156 rather
than specific sections. Finally, a
requirement about the type size of the
storage and disposal heading was added
to § 156.10(i)(2)(ix) after the container
regulations were proposed in 1994.
Today’s final rule maintains this
requirement and corrects the reference
to the child hazard warnings, which are
located in § 156.60(b).
N. Compliance Date (§ 156.159)
1. Final regulations. The final
regulations provide a 3–year compliance
period. Specifically, within 3 years from
today’s date, all pesticide products
distributed or sold by a registrant must
have labels that comply with the 40 CFR
part 156 requirements established in the
final rule. This gives registrants a phase
in period of 3 years to comply with the
labeling requirements in §§ 156.10(d)(7),
156.10(f), 156.10(i)(2)(ix), 156.140,
156.144, 156.146, and 156.156.
2. Changes. The most significant
change is that the phase-in period was
extended from 2 years to 3 years from
the publication of the final rule. In
addition, the regulatory language was
revised to make it more clear. EPA
agrees with some of the commenters
that a longer compliance period will
make it easier and less burdensome to
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comply with the label standards. To
facilitate compliance while trying to
minimize the impact on companies,
EPA lengthened the compliance period
for the label standards to 3 years. EPA
believes that a 3–year period is
sufficient based on the results of the
economic analysis. In addition, 3 years
is consistent with the phase-in period
for the nonrefillable container
regulations.
X. Relationship to Other Programs and
Agencies
Certain laws administered by EPA
and other agencies may affect the design
of pesticide containers or procedures
and standards for removal of residue
from pesticide containers. This section
identifies the laws that EPA considers to
have the most significant impact on
pesticide containers and containment.
The description of these laws is for
informational purposes only; no
changes are being made in the laws
described below. Nothing in this final
rule is intended to alter obligations
under other statutes.
A. Resource Conservation and Recovery
Act (RCRA)
Requirements under RCRA may affect
the handling of pesticide containers
under certain circumstances. RCRA
Subtitles C and I are described briefly
below.
FIFRA sections 19(f)(3) and 19(h)
specify that FIFRA section 19 does not
affect the requirements or authorities of
RCRA. Accordingly, today’s rule does
not alter any existing RCRA
requirements, and any applicable RCRA
provisions will apply in addition to the
provisions of any final rule issued under
FIFRA section 19. In addition, FIFRA
section 19(f)(1)(B)(iv) specifies that the
residue removal regulations may be
coordinated with requirements for
container rinsing under RCRA. As
outlined below, this rule provides for
coordination in this area.
1. Hazardous waste requirements.
Subtitle C of RCRA creates a cradle-tograve system for managing hazardous
wastes. RCRA Subtitle C regulations
include requirements for generators,
transporters, and others who handle
hazardous wastes. The regulations cover
any ‘‘solid waste’’ (defined at 42 U.S.C.
1004 and 40 CFR 261.2) that is listed as
a hazardous waste or exhibits a
characteristic of hazardous waste, as set
out in part 261. Pesticides (including
pesticide residues in containers that are
not empty per the RCRA definition in
§ 261.7) that are discarded or intended
to be discarded may qualify as
hazardous wastes, if the pesticide is a
hazardous waste as defined in § 261.33
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(discarded commercial chemical
products, off-specification products or
manufacturing intermediates, container
residues, and spill residues), or if they
exhibit a characteristic of hazardous
waste as described in part 261 subpart
C, and are not otherwise exempt from
regulation. A hazardous waste
remaining in a container is not subject
to Subtitle C regulation if, among other
things, the container is ‘‘empty’’ as
defined in § 261.7. A container is
‘‘empty’’ if the wastes are removed
pursuant to § 261.7(b)(1) or (b)(2), or, in
the case of an acute hazardous waste,
the container has been triple rinsed or
otherwise cleaned pursuant to
§ 261.7(b)(3). EPA believes that the
triple rinsing procedure provided in
today’s final rule meets the
requirements of § 261.7(b)(3), thus
meeting the directive in FIFRA section
19(f)(1)(B)(iv).
2. Underground storage tanks. RCRA
Subtitle I provides for the development
and implementation of a comprehensive
regulatory program for ‘‘underground
storage tanks’’ (USTs), defined at 42
U.S.C. 6991 and 40 CFR 280.12 as tanks
that are used to contain an
accumulation of ‘‘regulated substances’’
and whose volume (including
underground pipes connected thereto) is
10 percent or more below ground.
Regulated substances include petroleum
or substances defined as hazardous
under the Comprehensive
Environmental Response,
Compensation, and Liability Act of 1980
(CERCLA) (except hazardous wastes
regulated under RCRA Subtitle C).
CERCLA hazardous substances,
enumerated at 40 CFR part 302, include
a number of pesticides. UST
requirements at 40 CFR part 280 include
standards for new tanks as well as
requirements for leak detection, closure,
corrective action, and financial
responsibility.
EPA is not aware of the extent of
industry use of USTs to store
agricultural pesticides, and solicited
comment on the use of underground
tanks to store agricultural pesticides and
on the preferred means of coordinating
UST and FIFRA requirements. No
comments were received on the topic.
Because today’s final rule requires
secondary containment of any bulk
container holding pesticide,
underground storage would be
precluded unless the secondary
containment structure was also
underground. EPA considers that the
expense of such a construction makes it
unlikely that a facility would use
underground storage, and assumes that
since no comments were received,
underground storage of agricultural
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pesticides is generally avoided in the
industry. Furthermore, EPA has noted,
in its review of State regulations, that
underground storage of pesticides is
forbidden by States with bulk
containment regulations.
B. Clean Water Act
EPA has issued several regulations
under the Clean Water Act (CWA) (33
U.S.C. 1251 et seq.) that are related to
today’s rule and that affect some sectors
of the pesticide industry. The goal of the
CWA is to achieve zero discharge of
wastewater pollutants.
1. Pesticide chemicals category,
formulating, packaging and repackaging
effluent limitations guidelines,
pretreatment standards, and new source
performance standards: Final rule. On
November 6, 1996, EPA promulgated
regulations governing effluents from
pesticide formulating, packaging and
repackaging facilities (61 FR 57518, Ref.
57). Effluent guidelines establish
limitations on the pollutants discharged
into waters of the United States from
industrial point sources. The Pesticide
Formulating, Packaging and
Repackaging (PFPR) effluent guidelines
apply to facilities engaged in
formulating, packaging or repackaging
pesticides. The PFPR effluent guidelines
regulation set limitations for facilities in
two different regulatory subparts of 40
CFR part 455 (subparts C and E).
Subpart C applies to facilities that
discharge (or have the potential to
discharge) wastewater from pesticide
formulating, packaging, and/or
repackaging operations. All pesticides
with the exception of a few specific
exemptions are included under subpart
C. Subpart E applies only to refilling
establishments that repackage
agricultural pesticides into refillable
containers. Subpart E does not apply to
facilities that repackage non-agricultural
pesticides. The same formulators,
packagers, and repackagers (subpart E)
and refilling establishments (subpart E)
are affected by today’s final pesticide
container and containment rule.
However, the PFPR effluent guidelines
regulation does not include the other
types of facilities covered by today’s
containment rule, namely commercial
applicators and custom blenders.
Under the effluent guidelines rule,
refilling establishments are required to
achieve zero discharge of wastewater
pollutants. For these facilities, the zero
discharge regulation was based on
reuse, recycle and water conservation
practices, as well as contract hauling of
any non-reusable wastewater for off-site
disposal, if necessary. However, effluent
guidelines do not require specific
practices or control technologies. Many
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refilling establishments achieve the zero
discharge requirement through water
conservation and good housekeeping,
which includes repairing leaking valves
and fittings and collecting drips in pans
under appurtenances. Facilities that also
provide application services typically
reuse rinsate as make-up water for
application in accordance with the
label. Compliance with today’s pesticide
container and containment rule
regarding requirements for containment
structures, and adherence to the
recommendations regarding rinsate
collection will assist refilling
establishments in achieving the zero
discharge of pollutants required by the
effluent guidelines.
Under the PFPR effluent guidelines,
subpart C facilities (formulators,
packagers, and repackagers) are required
to either achieve zero discharge of
wastewater pollutants or to implement
specific reuse, recycle, and water
conservation practices (Pollution
Prevention Alternative). For example,
under the pollution prevention
alternative, facilities must reuse their
rinsates directly into the formulation or
store rinsates for use in future
formulation of the same or a compatible
product.
When the PFPR effluent regulations
were proposed in April 1994 (Ref. 64),
the scope of subpart C included all
pesticide active ingredients (PAIs) (with
the exception of sodium hypochlorite
and the partial exemption of specified
sanitizers) and a wide variety of
associated wastewater sources. EPA
published a supplemental notice on
June 8, 1995 (Ref. 61) which refined the
scope of PAIs and wastewater sources.
In the final rule, most sanitizer products
were excluded, based on a number of
factors, such as:
• Sanitizer products are formulated
for the purposes of their labeled end use
to ‘‘go down the drain;’’
• Sanitizer active ingredients are
more likely to be sent to Publicly
Owned Treatment Works (POTWs) in
greater concentrations and volumes
from their labeled end use than from
rinsing formulating equipment at the
PFPR facility;
• Biodegradation data received with
comments on some of these sanitizer
active ingredients support the
hypothesis that they do not pass
through POTWs;
• These sanitizer active ingredients
represent a large portion of the low
toxicity PAIs considered for regulation
at the time of proposal; and
• Many sanitizer solutions containing
these active ingredients are cleared by
the Food and Drug Administration
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(FDA) as indirect food additives under
21 CFR 178.1010.
The final PFPR effluent guidelines
rule (subpart C) combined the pool
chemicals exemption into the sanitizer
exemption and exempted other pool
chemicals in addition to the only pool
chemical in the proposal, sodium
hypochlorite. The additional chemicals
that are included in the definition of
pool chemicals in 40 CFR 455.10
include calcium hypochlorite, lithium
hypochlorite, potassium hypochlorite,
chlorinated isocyanurate compounds
and halogenated hydantoins.
The bulk containment requirements
in today’s rule are consistent with the
control technologies which are the basis
for the PFPR effluent guidelines for
refilling establishments (subpart E). In
addition, the repackaging and refillable
container requirements of today’s rule,
particularly the adherence to the
recommendations regarding rinsate
collection, will aid facilities in
collecting and reusing rinsates to meet
the zero discharge/pollutant prevention
alternative requirements of subpart C of
the PFPR effluent guidelines.
2. National Pollutant Discharge
Elimination System (NPDES) - Storm
Water Phase II Final Rule. EPA issued
final regulations on December 8, 1999
(64 FR 68722, Ref. 52) addressing storm
water discharges. The regulation
established a ‘‘no exposure’’ exemption
for storm water discharges from
facilities where industrial materials and
activities are not exposed to storm
water. Upon review of earlier
regulations that excluded storm water
discharges from certain categories of
light industry from NPDES permit
requirements, a court invalidated the
light industry exemption. In 1992, the
Ninth Circuit court concluded that the
exemption impermissibly relied on the
unsubstantiated judgment of the facility
operator to determine applicability of
the exemption. The new rule
established in 1999 now allows the
exemption, but requires that the facility
meet certain conditions and provide a
certification for tracking and
accountability. ‘‘No exposure’’ means
that all industrial materials or activities
are protected by storm-resistant
sheltering so they are not exposed to
rain, snow, snowmelt or runoff. (40 CFR
122.26(g))
Pesticide refilling operations and bulk
storage operations required to apply for
and obtain NPDES permits for storm
water discharges associated with such
operations may take advantage of this
exemption if they provide a certification
of ‘‘no exposure’’ and maintain the
certified conditions at the facility. Even
when an owner/operator certifies to no
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exposure, the NPDES permitting
authority may still require a permit if it
determines that there is a discharge
interfering with water quality standards.
This will provide an added incentive to
place all tanks within secondary
containment that is protected from the
elements. Facilities that are not exempt
will have to get a discharge permit.
3. Effluent guidelines and standards
for the transportation equipment
cleaning (TEC) Industry. On August 14,
2000, EPA published a final rule (65
CFR 49665, Ref. 51) establishing
restrictions on the discharge of
wastewater from cleaning the interiors
of tank trucks, rail tank cars, inland tank
barges, ocean/sea tankers, and other
similar tanks used to transport
materials, including agricultural
chemicals and fertilizers. The TEC
regulations do not apply to wastewaters
generated from cleaning the interiors of
pesticide drums or intermediate bulk
containers (IBCs), defined as portable
containers with 450 liters (119 gallons)
to 3,000 liters (793 gallons) capacity.
EPA subsequently studied the Industrial
Container and Drum Cleaning Industry.
The Preliminary Data Summary Industrial Container and Drum Cleaning
Industry (EPA–821–R–02–011 and Ref.
48) can be downloaded from the
following link: http://www.epa.gov/
waterscience/pollcontrol/drum/
index.html.
4. Spill prevention control and
countermeasures (SPCC). On July 17,
2002, (67 FR 47042, Ref. 47), EPA
promulgated regulations under section
311(j)(1)(C) of the Clean Water Act
(known as the SPCC regulations) for the
prevention of oil spills into navigable
waters and adjoining shorelines. The
regulations apply to facilities that,
because of their location, could
reasonably be expected to discharge oil
into navigable waters or adjoining
shorelines. Part 112 of 40 CFR outlines
requirements for both the prevention
and the response to oil spills. Facilities
that are subject to the SPCC regulations
include any non-transportation-related
onshore or offshore facility engaged in
drilling, producing, gathering, storing,
processing, refining, transferring,
distributing, using, or consuming oil
and oil products, which due to its
location, could reasonably be expected
to discharge oil, in quantities that may
be harmful, into navigable waters of the
United States or adjoining shorelines.
Because the definition of ‘‘oil’’ under
CWA section 311 is very broad
(including oil ‘‘of any kind and in any
form’’), it could potentially include
pesticides that contain oil or are oilbased. EPA expects that comparatively
few, if any, of the facilities covered by
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today’s pesticide container and
containment rule are also subject to
SPCC requirements, but if any are, both
today’s rule and SPCC requirements
apply. On December 12, 2005, EPA
proposed two separate amendments to
the SPCC Rule. One of them (Ref. 24)
streamlines the regulatory requirements
for qualified facilities and equipment
regulated under 40 CFR part 112 and
proposes a separate extension of the
compliance date for farms. The other
amendment (Ref. 23) extends the SPCC
compliance dates for all facilities.
C. Occupational Safety and Health
Administration Requirements
The Occupational Safety and Health
Act (U.S.C. 2601 et seq.) addresses
occupational safety and health hazards
by establishing requirements for
employers and employees and
authorizing the Occupational Safety and
Health Administration (OSHA) to
establish mandatory occupational safety
and health standards.
Tanks and containers that are used to
store flammable and combustible
liquids in occupational settings are
subject to OSHA requirements under 29
CFR 1910.106. For storage tanks,
§ 1910.106(b) contains design and
construction requirements, including
standards for materials, spacing,
venting, drainage and diking, fire and
flood resistance, and testing for strength
and tightness. Section 1910.106(c)
contains specifications for piping,
valves, and fittings. Section 1910.106(d)
sets out design and construction
requirements for containers and
portable tanks, and also contains
specifications for storage areas. Today’s
regulations do not contradict or
supercede any existing OSHA
requirements, and any applicable OSHA
provisions will apply in addition to the
provisions of today’s rule.
D. Department of Transportation
Hazardous Materials Regulations
The Hazardous Materials
Transportation Act of 1974, (49 U.S.C.
1801 et seq) authorizes DOT to
designate as hazardous materials those
materials that may pose unreasonable
risk to health and safety or property,
and regulate the handling and
transportation of such materials. The
DOT regulations and their relationship
to today’s final pesticide container and
containment regulations are discussed
in detail in Unit IV. and many other
places throughout this preamble.
XI. FIFRA Mandated Reviews
In accordance with FIFRA sec. 25(a),
the Agency submitted a draft of this
final rule to the FIFRA Scientific
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Advisory Panel (SAP), the Secretary of
Agriculture, and the Committee on
Agriculture in the House of
Representatives, and the Committee on
Agriculture, Nutrition, and Forestry in
the United States Senate.
The FIFRA SAP waived its review of
this final rule because the significant
scientific issues involved have already
been reviewed by the SAP and
additional review isn’t necessary. The
USDA did not submit any official
comments.
XII. References
The following is a listing of the
documents that are specifically
referenced in this final rule. These
documents, and other supporting
materials, are included in the docket
established for this rulemaking under
docket ID No.EPA-HQ-OPP–2005–0327
at http://www.regulations.gov.
1. Ag Container Recycling Council.
‘‘ACRC Celebrates 10 Years’’, in ‘‘News
Bits from the Ag Container Recycling
Council,’’ Summer (2002).
2. Beaver, B.A. and W.D. Goetsch.
‘‘Container Recycling in Illinois,’’ 1994
Illinois Agricultural Pesticides
Conference, (1994).
3. Dwinell, S., 1992. Florida
Department of Environmental
Regulation, ‘‘Final Report: Jackson
County Pesticide Container Recycling
Demonstration Project,’’ (1992).
4. Dwinell, S., 1991. Florida
Department of Environmental
Regulation, ‘‘Final Report: South Florida
Pesticide Container Recycling
Demonstration Project,’’ (1991).
5. Federal Trade Commission.
‘‘Guides for the Use of Environmental
Marketing Claims,’’ 16 CFR 260, (2006).
6. Formulogics, 1991. ‘‘Report to
Mitchell System: Data Generation Rinsing Studies,’’ September 24 (1991).
7. Formulogics, 1991. ‘‘Triple Rinsing
of Containers: Rinsing Variables,’’
results of a study conducted for U.S.
EPA, December 2 (1991).
8. Formulogics, 1990. ‘‘Container
Rinsing: Methodology Support,’’ testing
conducted for the U.S. EPA, 1990.
9. Frieberg, D. Iowa Fertilizer and
Chemical Association, ‘‘Environmental
Cleanup of Fertilizer and Agricultural
Chemical Dealer Sites,’’ (1991).
10. Hudak, C.M., North Carolina
Department of Agriculture and
Consumer Services. ‘‘Pesticide
Container Recycling in North Carolina’’
presented at 2000 National Pesticide
Stewardship Alliance Conference,
(2000).
11. Kammel, D., R. Noyes, G.
Riskowski, and V. Hofman. ‘‘Designing
Facilities for Pesticide and Fertilizer
Containment,’’ MidWest Plan Service–
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37, Iowa State University, Ames, Iowa
(1991).
12. Michigan Department of
Agriculture. ‘‘Environmental
Stewardship and the Michigan
Department of Agriculture: A Report to
Governor John Engler’’ (1993).
13. Minnesota Department of
Agriculture. ‘‘Empty Pesticide Container
Collection and Recycling Program:
Annual Report,’’ (1996).
14. Moye, Anson H., et al. ‘‘Final
Report: Work Assignment - Triple
Rinse,’’ research conducted for U.S.
EPA, January 31 (1995).
15. National Agricultural Chemicals
Association, ‘‘NACA Container
Management Task Force Empty
Pesticide Container Rinsing Study:
Product Information and Analytical
Results,’’ October 16 (1990).
16. United Nations Economic
Commission for Europe (UNECE).
‘‘Globally Harmonized System of
Classification and Labeling of Chemicals
(GHS)’’ (2005).
17. Palmer, L. and R. Hansen.
Minnesota Department of Agriculture
[Information on pesticide container
collection programs], Personal
communication to members of the
Minnesota Pesticide Container Advisory
Committee, September 30 (1991).
18. Poncin, S. Minnesota Department
of Agriculture. ‘‘Rinsing Problems
Associated with Pesticides that are
Formulated as Flowable,’’ September
(1995).
19. U.S. EPA, 2006. ‘‘Response to
Comment Document: Standards for
Pesticide Containers and Containment,’’
(2006).
20. U.S. EPA, 2006. ‘‘Rinsing
Procedures for Dilutable Pesticide
Products in Rigid Containers,’’ (2006).
21. U.S. EPA, 2005. ‘‘Economic
Analysis of the Bulk Pesticide
Containment Structures Final
Regulation,’’ November 15 (2005).
22. U.S. EPA, 2005. ‘‘Economic
Analysis of the Pesticide Container
Design and Residue Removal
Standards,’’ November 21 (2005).
23. U.S. EPA, 2005. ‘‘Oil Pollution
Prevention; Non-Transportation Related
Onshore Facilities: Proposed Rule,’’ 70
FR 73517, December 12 (2005).
24. U.S. EPA, 2005. ‘‘Oil Pollution
Prevention; Spill Prevention, Control,
and Countermeasure Plan Requirements
- Amendments: Proposed Rule,’’ 70 FR
73523, December 12 (2005).
25. U.S. EPA, 2005. ‘‘State Bulk
Pesticide Containment Regulations Scope and Definition of Bulk,’’ February
2 (2005).
26. U.S. EPA, 2005. ‘‘Summary of
Discussions re: Pesticide Container
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47415
Collection Program Observations,’’
November 15 (2005).
27. U.S. EPA, 2005. ‘‘Summary of
Information on On-Farm Bulk Storage
and Repackaging from State Contacts
from States with Regulations that
Include Farms,’’ February 14 (2005).
28. U.S. EPA, 2005. ‘‘Summary of
State Responses to EPA Inquiries About
Bulk Storage on Farms,’’ February 14
(2005).
29. U.S. EPA, 2005. ‘‘Summary of
Telephone Conversations with
Packaging Industry re: Dry Bulk
Containers,’’ February (2005).
30. U.S. EPA, 2006. ‘‘Supporting
Statement for an Information Collection
Request: Standards for Pesticide
Containers and Containment (Final
Rule), June 21, (2006).
31. U.S. EPA, 2004. ‘‘Meeting
Summary,’’ July 19 (2004).
32. U.S. EPA, 2004. ‘‘Standards for
Pesticide Containers and Containment:
Proposed Rule; Extension of Comment
Period,’’ 69 FR 50114, August 13 (2004).
33. U.S. EPA, 2004. ‘‘Standards for
Pesticide Containers and Containment:
Proposed Rule; Partial Reopening of the
Comment Period,’’ 69 FR 39392, June 30
(2004).
34. U.S. EPA, 2004. ‘‘Summary Tables
of State Bulk Pesticide Containment
Regulations,’’ January 23 (2004).
35. U.S. EPA, 2003. ‘‘Analysis and
Summary of CSMA Data,’’ March 5
(2003).
36. U.S. EPA, 2003. ‘‘Analysis and
Summary of Formulogics Agricultural
Formulation/Container Data,’’ February
24 (2003).
37. U.S. EPA, 2003. ‘‘Analysis and
Summary of Formulogics Household,
Institutional and Industrial Data,’’
March 5 (2003).
38. U.S. EPA, 2003. ‘‘Analysis and
Summary of Formulogics Quick Rinse
Data,’’ February 26 (2003).
39. U.S. EPA, 2003. ‘‘Analysis and
Summary of NACA Triple Rinse data,’’
March 4 (2003).
40. U.S. EPA, 2003. ‘‘Analysis and
Summary of Pressure Rinse Data,’’
March 5 (2003).
41. U.S. EPA, 2003. ‘‘Analysis and
Summary of University of Florida Quick
Rinse Data,’’ February 26 (2003).
42. U.S. EPA, 2003. ‘‘Comparison of
Triple Rinsing Data for Proposed and
Final Rule,’’ July 7 (2003).
43. U.S. EPA, 2003. ‘‘Information
About Container Rejections from
Recycling Programs,’’ July 15 (2003).
44. U.S. EPA, 2003. ‘‘Label Review
Manual: Third Edition,’’ EPA 735–B–
03–001, August (2003).
45. U.S. EPA, 2003. ‘‘Revised Scope of
the Container Regulations (NonAntimicrobial Products,’’ January 6
(2003).
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46. U.S. EPA, 2003. ‘‘Summary of
Conference Call with Wisconsin
Department of Agriculture Staff on
Containment Regulations,’’ July 29
(2003).
47. U.S. EPA, 2002. ‘‘Oil Pollution
Prevention and Response: NonTransportation-Related Onshore and
Offshore Facilities: Final Rule,’’ 67 FR
47042, July 17 (2002).
48. U.S. EPA, 2002. ‘‘Preliminary Data
Summary for Industrial Container and
Drum Cleaning Industry,’’ EPA–821–R–
02–011, June (2002).
49. U.S. EPA, 2001. ‘‘Disposal
Instructions on Non-Antimicrobial
Residential/Household Use Pesticide
Product Labels,’’ Pesticide Registration
Notice 2001–6, September 7 (2001).
50. U.S. EPA, 2001. ‘‘Regulations
Under the Federal Insecticide,
Fungicide, and Rodenticide Act for
Plant-Incorporated Protectants
(Formerly Plant-Pesticides): Final Rule,’’
66 FR 37771, July 19 (2001).
51. U.S. EPA, 2000. ‘‘Effluent
Limitations Guidelines, Pretreatment
Standards, and New Source
Performance Standards for the
Transportation Equipment Cleaning
Point Source Category: Final Rule,’’ 65
FR 49665, August 14 (2000).
52. U.S. EPA, 1999. ‘‘National
Pollutant Discharge Elimination SystemRegulations for Revision of the Water
Pollution Control Program Addressing
Storm Water Discharges: Final Rule,’’ 64
FR 68722, December 8 (1999).
53. U.S. EPA, 1999. ‘‘Standards for
Pesticide Containers and Containment:
Proposed Rule; Partial Reopening of the
Comment Period,’’ 64 FR 56918,
October 21 (1999).
54. U.S. EPA, 1998. ‘‘Additional
Guidance on Final FIFRA Section
6(a)(2) Regulations for Pesticide Product
Registrants,’’ Pesticide Registration
Notice 98–4, August 4 (1998).
55. U.S. EPA, 1998. ‘‘Guidance on
Final FIFRA Section 6(a)(2) Regulations
for Pesticide Product Registrants,’’
Pesticide Registration Notice 98–3,
April 3 (1998).
56. U.S. EPA, 1998. ‘‘Notifications,
Non-notifications and Minor
Formulation Amendments,’’ Pesticide
Registration Notice 98–10, October 22
(1998).
57. U.S. EPA, 1996. ‘‘Pesticide
Chemicals Category, Formulating,
Packaging and Repackaging Effluent
Limitations Guidelines, Pretreatment
Standards, and New Source
Performance Standards: Final Rule,’’ 61
FR 57518, November 6 (1996).
58. U.S. EPA, 1996. ‘‘Toxicologically
Significant Levels of Pesticide Active
Ingredients,’’ Pesticide Registration
Notice 96–8, October 31 (1996).
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59. U.S. EPA, 1995. ‘‘Bulk Pesticide
Transfers,’’ Memorandum from Jesse
Baskerville, U.S. EPA, to U.S. EPA
Regional Pesticides and Toxics Division
Directors and Regional Counsels, March
22 (1995).
60. U.S. EPA, 1995. ‘‘Notice of Interim
Determination of Adequacy of Certain
State and Territorial Programs,’’ 60 FR
24855, May 10 (1995).
61. U.S. EPA, 1995. ‘‘Pesticide
Chemicals Category, Formulating,
Packaging and Repackaging Effluent
Limitations Guidelines, Pretreatment
Standards, and New Source
Performance Standards: Supplemental
Notice,’’ 60 FR 30217, June 8 (1995).
62. U.S. EPA, 1995. ‘‘Pesticides;
Technical Amendments: Final Rule,’’ 60
FR 32094, June 19 (1995).
63. U.S. EPA, 1994. ‘‘Bulk Policy
Question & Answer Document,’’
February 3 (1994).
64. U.S. EPA, 1994. ‘‘Pesticide
Chemicals Category, Formulating,
Packaging and Repackaging Effluent
Limitations Guidelines, Pretreatment
Standards, and New Source
Performance Standards: Proposed
Rule,’’ April 14 (1994).
65. U.S. EPA, 1994. ‘‘Recycling Empty
Aerosol Pesticide Containers,’’ Pesticide
Registration Notice 94–2, May 16 (1994).
66. U.S. EPA, 1994. ‘‘Standards for
Pesticide Containers and Containment:
Proposed Rule,’’ 59 FR 6712, February
11 (1994).
67. U.S. EPA, 1994. ‘‘State Pesticide
Residue Removal Compliance Programs;
Notice of Interim Determination of
Adequacy; Correction,’’ 59 FR 9214,
February 25 (1994).
68. U.S. EPA, 1993. ‘‘Interim
Determination of Adequacy of State
Pesticide Residue Removal Programs,’’
58 FR 43994, August 18 (1993).
69. U.S. EPA, 1993. ‘‘Notice of Interim
Determination of Adequacy of Certain
State Programs,’’ 58 FR 65989,
December 17 (1993).
70. U.S. EPA, 1992. ‘‘State of the
States: Pesticide Storage, Disposal and
Transportation,’’ prepared for EPA by
Mitchell Systems Corporation, EPA
publication number EPA 734–R–92–12
(1992).
71. U.S. EPA, 1991. ‘‘Amendment to
the July 11, 1977 Enforcement Policy
Applicable to Bulk Shipment of
Pesticides,’’ March 4 (1991).
72. U.S. EPA, 1984. ‘‘Clarification of
Label Improvement Program for
Farmworker Safety and Pesticide
Storage and Disposal Instructions,’’
Pesticide Registration Notice 84–1,
February 17 (1984).
73. U.S. EPA, 1983. Office of Pesticide
Programs, ‘‘Label Improvement Program
- Storage and Disposal Label
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Statements,’’ Pesticide Registration
Notice 83–3 (1983).
74. U.S. EPA, 1979. ‘‘National
Pollution Discharge Elimination System
(NPDES) Best Management Practices
Guidance Document,’’ EPA–600/9–79–
045, December (1979).
75. U.S. EPA, 1977. ‘‘Enforcement
Policy Applicable to Bulk Shipment of
Pesticides,’’ July 11 (1977).
76. U.S. EPA, 1976. ‘‘Pesticide
Enforcement Policy Statement on
Structural Pest Control: Use and
Labeling of Service Containers for the
Transportation or Temporary Storage of
Pesticides,’’ (1976).
77. Viera, K. Clorox [Data from
container rinsing tests conducted by
Chemical Specialties Manufacturers
Association], Personal communication
to U.S. EPA, July 13 (1993).
78. U.S., EPA, 2000. ‘‘Analysis of
Products that Meet the Scope Criteria:
Toxicity Category III Only,’’ November
27 (2000).
XIII. Statutory and Executive Order
Reviews
A. Executive Order 12866
Under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993),
the Office of Management and Budget
(OMB) has determined that this final
rule is a ‘‘significant regulatory action’’
because these requirements may raise
novel legal or policy issues arising out
of legal mandates, the President’s
priorities, or the principles set forth in
the Executive Order. Accordingly, EPA
submitted a draft final rule to OMB for
review under Executive Order 12866
and any changes made in response to
OMB recommendations have been
documented in the docket for this
rulemaking as required by sec. 6(a)(3)(E)
of the Executive Order.
In addition, EPA has prepared two
Economic Analyses (EAs) of the
potential costs and benefits associated
with this rule, one for the container
requirements and another for the
containment requirements. The reason
for having two EAs is because the
regulated community differs in each
case. For example, the container
requirements affect pesticide
formulators and refillers of all pesticides
while the containment requirements
affect retailers, for-hire applicators and
custom blenders of agricultural
pesticides. The EAs, entitled Economic
Analysis of the Pesticide Container
Design and Residue Removal Standards
(Ref. 22) and Economic Analysis of the
Bulk Pesticide Containment Structure
Regulations (Ref. 21), are available in
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the docket for this rule and are briefly
summarized here.
EPA estimates the total cost of the
final rule to be $11.3 million ($8.37
million for containers + $2.93 million
for containment) and the total benefits
from the final rule to be $17 - 23.4
million. When the estimated cost of the
final rule is compared to the estimated
cost for the proposed rule, there is an
annual cost reduction of approximately
$27.4 - $38.6 million. This reduction in
estimated cost is due to the choices
made in the final rule that lead to a
narrowing in the scope of regulated
entities and products that are subject to
the final rule. During the first year,
regulated facilities will experience an
increase in total paperwork cost burden
of $1 million (containment) and $7.0
million (containers) due primarily to
inspection and recordkeeping costs. For
containers, in the second year and
continuing thereafter, total paperwork
cost burden per facility will decrease to
25 hours from 81 hours in the first year,
reducing paperwork burden costs to
$4.1 million annually.
Over 20 respondents submitted
general comments on the Regulatory
Impact Analyses (RIAs) or EAs for the
proposed rule. Nearly all of the
commenters wanted EPA to reevaluate
the economic assessments. The most
common comments were: 1) The costs
far outweigh the benefits; 2) costs were
underestimated; 3) benefits were
overestimated; 4) this is a major rule,
contrary to EPA’s assessment; 5) the rule
will have a significant impact on
medium and large formulators as well as
small formulators; 6) the rule will have
a general impact on various industry
segments; and 7) the rule does not
comply with the standards of the
Executive Order. Commenters who
objected to the cost estimates mainly
disagreed with EPA’s estimate of the
cost of complying with the six 9’s
residue removal standard. State
regulatory agencies predicted that the
rule would increase their workload and
expressed the hope that EPA would
increase State funding.
EPA reopened the comment period on
the proposed rule on October 21, 1999
(64 FR 56918, Ref. 53) on three issues,
proposing to reduce the scope of the
container standards, add an exemption
for certain antimicrobial pesticides, and
adopt some of the Department of
Transportation (DOT) hazardous
materials regulations. These potential
changes decreased the estimated
economic impact by reducing the
number of pesticide products subject to
the container requirements compared to
the original proposal.
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Major changes resulted in cost
reduction from the economic analysis
for the proposed rule. Among these is
the elimination of the requirement to
demonstrate the hydraulic conductivity
of containment structures, lowering of
the residue removal standard from six
9’s to four 9’s, and limiting of rinsetesting requirement to those
formulations expected to be
problematic.
B. Paperwork Reduction Act (PRA)
The information collection
requirements in this final rule have been
submitted to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq. The Information Collection Request
(ICR) document prepared by EPA for
this final rule has been assigned EPA
ICR No. 1631.02, and OMB control
number 2070–0133. Consistent with the
procedures at 5 CFR 1320.11, EPA
sought comment on two Information
Collection Request (ICR) documents that
were submitted to OMB in conjunction
with issuing the proposed rule
(identified under EPA ICR No. 1631.01
and No. 1632.01). For the final rule, the
two ICR documents were combined into
one ICR document, which reflects the
information collection provisions in this
final rule. The ICR document for this
final rule (identified under EPA ICR No.
1631.02) (Ref. 30) is included in the
docket for the final rule.
Under the PRA, an agency may not
conduct or sponsor, and a person is not
required to respond to a collection of
information unless it displays a
currently valid OMB control number.
The OMB control numbers for EPA’s
regulations codified in Chapter 40 of the
CFR, after appearing in the preamble of
the final rule, are listed in 40 CFR part
9, are displayed either by publication in
the Federal Register or by other
appropriate means, such as on the
related collection instrument or form, if
applicable. The display of OMB control
numbers in certain EPA regulations is
consolidated in 40 CFR part 9. For the
ICR activity contained in this final rule,
in addition to displaying the applicable
OMB control number in this Unit, the
Agency is amending the table in 40 CFR
9.1 to list the OMB control number
assigned to this ICR activity. Due to the
technical nature of the table, EPA finds
that further notice and comment about
amending the table is unnecessary. As a
result, EPA finds that there is good
cause under section 553(b)(B) of the
Administrative Procedures Act (APA), 5
U.S.C. 553(b)(B), to amend this table
without further notice and comment.
Under the PRA, burden means the
total time, effort, or financial resources
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47417
expended by persons to generate,
maintain, retain, disclose or provide
information to or for a Federal agency.
This includes the time needed to review
instructions; develop, acquire, install,
and utilize technology and systems for
the purposes of collecting, validating,
and verifying information, processing
and maintaining information, and
disclosing and providing information;
adjust the existing ways to comply with
any previously applicable instructions
and requirements; train personnel to be
able to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
In this final rule, the information
collection requirement burden on the
regulated community includes the
administrative burden associated with
keeping monthly inspection and
maintenance records for bulk pesticide
containment structures. The regulated
community’s administrative burden is
defined as the time spent to record and
file the inspection and maintenance of
the bulk pesticide containment
structures per month. There is not a
requirement to submit the records or
reports to the Agency, however, EPA or
its representatives may, from time to
time, request information under these
regulations to ensure compliance with
the regulation.
The two ICRs for the proposed rule
were combined into a single ICR for the
final rule. This ICR document provides
detailed presentations of the estimated
annual burden and costs for 3 years,
which represents the maximum OMB
approval period for any collection
activity, after which the Agency must
seek renewal of the ICR approval from
OMB every 3 years for as long as the
requirements exist.
1. Container burden. The public
reporting burden for this collection of
information is estimated to be 66 hours
in the first year of compliance with this
rule for approximately 1,804 pesticide
registrant respondents, and 10 hours in
subsequent years. For an estimated
16,795 agricultural pesticide refiller
respondents, the reporting burden is 7.5
hours per year. For an estimated 322
swimming pool supply companies, the
reporting burden is 7.5 hours per year.
The total annual paperwork burden
across all pesticide registrant
respondents, assuming that 1,804
facilities will be affected by the
requirements, is 112,209 hours in first
year, and 11,185 hours in all other
years. The total annual paperwork
burden across all agricultural pesticide
refiller respondents, assuming 16,795
facilities will be affected by the
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requirements, is 125,963 hours. The
total annual paperwork burden across
all swimming pool supply companies,
assuming 322 facilities will be affected
by the requirements, is 2,415 hours.
2. Containment burden. The public
recordkeeping burden for this collection
of information is estimated to be 7.5
hours for approximately 4,665
respondents in the first year after
promulgation of this rule, which
includes initial rule familiarization. The
average annual burden per respondent
for subsequent years is estimated to be
7.5 hours. The total annual paperwork
burden across all respondents, assuming
that 4,665 facilities will be affected by
the requirement, is 34,988 hours per
year.
In comments filed after reviewing the
proposed ICRs in 1994, OMB
commented that EPA should consider
less burdensome testing requirements
that meet the objective that disposal of
containers poses no unreasonable risk to
health of the environment. As discussed
previously, EPA has modified the
requirements to be less burdensome,
decreasing the total industry burden for
the final rule. The decrease in burden
results mainly from the elimination of
the hydraulic conductivity standard for
containment structures, lowering of the
residue removal standard to four 9’s,
and requiring residue removal testing
only for problematic formulations.
The Agency is seeking additional
comments on the paperwork burden
estimates related to the provision in the
final rule that allows States with
existing regulations (§ 165.97) to request
the authority to continue implementing
its State containment regulations in lieu
of EPA’s regulations. As discussed
previously, EPA added this provision in
response to comments asking EPA to
consider existing State regulations.
Since this provision and related burden
estimates were not part of the ICRs that
were prepared and for which public
comment was sought in conjunction
with the proposed rule, EPA is
providing this opportunity for public
comment. Direct your comments on this
to EPA using the public docket that has
been established for this final rule
(docket ID number EPA–HQ–OPP–
2005–0327) at http://
www.regulations.gov. In addition, send
a copy of your comments to OMB at:
Office of Information and Regulatory
Affairs, Office of Management and
Budget, 725 17th St., NW., Washington,
DC 20503, Attention: Desk Office for
EPA ICR No. 1361.02. Since OMB is
required to complete its review of the
ICR between 30 and 60 days after
August 16, 2006, please submit your
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comments no later than September 15,
2006.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency hereby
certifies that this final rule will not have
a significant adverse economic impact
on a substantial number of small
entities. This determination is based on
the Agency’s two economic analyses
performed for this rulemaking, which
are briefly summarized in Unit XIII.A.,
and copies of which are available in the
docket for this rulemaking (Refs. 21 and
22). The following is a brief summary of
the factual basis for this certification.
Under the RFA, small entities include
small businesses, small organizations,
and small governmental jurisdictions.
For purposes of assessing the impacts of
today’s rule on small entities, small
entity is defined in accordance with the
RFA as: (1) A small business as defined
by the Small Business Administration’s
(SBA) regulations at 13 CFR 121.201; (2)
a small governmental jurisdiction that is
a government of a city, county, town,
school district, or special district with a
population of less than 50,000; and (3)
a small organization that is any not-forprofit enterprise which is independently
owned and operated and is not
dominant in its field. Based on the
industry profiles for this rulemaking
that EPA prepared as part of the
Economic Analyses, EPA has
determined that this final rule is not
expected to impact any small not-forprofit organizations or small
governmental jurisdictions. As such,
small entity for purposes of this final
rule is synonymous with small business.
In addition, for purposes of analyzing
the potential impacts of this final rule
on small businesses, the Agency
disaggregated the universe of potentially
impacted small business into
subcategories of large-small businesses,
medium-small businesses, and smallsmall businesses. The analysis
disaggregated the impacts of small
businesses into these sub-categories
because the SBA size standard for small
businesses, which are primarily
intended to define whether a business
entity is eligible for Federal government
programs and preferences reserved for
small businesses (13 CFR 121.101), may
not be representative of all small
businesses in the industry sectors
impacted by this rulemaking. (See
section 632(a)(1) of the Small Business
Act.) The SBA size standard is generally
based on the number of employees an
entity in a particular industrial sector
may have. For example, in the Pesticide
and Other Agricultural Chemical
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Manufacturing sector (i.e., NAICS code
325320) approximately 92% of the
industries would be classified as small
businesses under the SBA definition
(500 or fewer employees). However,
60% of the SBA defined small
companies have 1 to 19 employees,
which are considered small-small
businesses in the Agency’s analysis. By
disaggregating the potential impacts of
this final rule on small businesses, the
Agency was able to consider the
distribution of the estimated impacts
among the universe of potentially
impacted small businesses, particularly
potential impacts on the small-small
businesses.
Considering just the container
requirements, the estimated costs of
compliance for the universe of
potentially impacted small businesses
in each of the regulated industries as a
proportion of their current revenues are
estimated to be less than 1 percent.
Specifically, using the SBA definition of
small businesses, the costs of
compliance for all small businesses are
estimated to be less than 0.02 percent of
the current average entity revenues.
Looking at the estimated impacts using
the disaggregated small business subcategories used in the Agency’s analysis
(which further divides small businesses
into large-small, medium-small and
small-small business within each of the
regulated industries), no small-small
business is estimated to incur costs
which account for more than 0.04
percent of current average entity
revenues.
Considering just the containment
requirements, the estimated costs of
compliance for the universe of
potentially impacted small businesses
as a proportion of their current revenues
are estimated to be less than 1 percent,
except for small commercial applicators.
When only looking at commercial
applicators, and using the SBA
definition of small business, the costs of
compliance for potentially impacted
small commercial applicators to install
new secondary containment units are
estimated to be as high as 2.7 percent of
the current average entity revenues.
Small-small commercial applicators,
based on the disaggregated small
business sub-categories used in the
Agency’s analysis, may face costs of
compliance that are as much as 7.8
percent of the current average entity
revenues. However, only 6 of the 3,000
small commercial applicators were
identified as small-small commercial
applicators that will need to install both
a secondary containment unit and a
containment pad and thus are estimated
to be impacted in this way. The costs of
compliance for potentially impacted
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small commercial applicators to retrofit
existing containment structures are
estimated to be less than 1 percent of
the current average entity revenues.
For agricultural pesticide refillers, the
other industry estimated to be impacted
by the containment regulations, the
costs of compliance for small
agricultural pesticide refillers are
estimated to be less than 0.18 percent of
current average entity revenues using
the SBA definition of small businesses,
and less than 0.34 percent of current
average entity revenues based on the
disaggregated small-small business subcategory used in the Agency’s analysis.
Considering the overall impact of this
final rule on the universe of potentially
impacted small businesses using the
SBA definition for small business, the
Agency has determined that this final
rule will not have a significant adverse
economic impact on a substantial
number of small entities.
In general, EPA strives to minimize
potential adverse impacts on small
entities when developing regulations to
achieve the environmental and human
health protection goals of the statute
and the Agency. In doing so for this
particular rule, as discussed in more
detail previously, the major changes that
EPA made to the proposed requirements
resulted in significant reductions in the
potential costs of compliance for this
rulemaking.
jlentini on PROD1PC65 with RULES2
D. Unfunded Mandates Reform Act
(UMRA)
Pursuant to Title II of the Unfunded
Mandates Reform Act of 1995 (Public
Law 104–4), EPA has determined that
this action does not contain a Federal
mandate that may result in expenditures
of $100 million or more for State, local,
and tribal governments, in the aggregate,
or for the private sector in any one year.
As described in Unit XIII.A., the annual
costs associated with this action are
estimated to total $11.3 million ($8.37
millioin for containers + $2.93 million
for containment). This cost represents
the incremental cost to registrants,
pesticide dealers, commercial
applicators and custom blenders
attributed to the requirements in this
action. Accordingly, this action is not
subject to the requirements of sections
202 and 205 of UMRA.
E. Executive Order 13132
Pursuant to Executive Order 13132,
entitled Federalism (64 FR 43255,
August 10, 1999), EPA has determined
that this final rule does not have
federalism implications, because it
would not have substantial direct effects
on the States, on the relationship
between the national government and
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Jkt 208001
the States, or on the distribution of
power and responsibilities among the
various levels of government, as
specified in the Order. Under
cooperative agreements with EPA,
States will be involved in compliance
monitoring and enforcement activities,
but are not otherwise expected to engage
in the activities regulated by this rule.
Thus, Executive Order 13132 does not
apply to this rule.
F. Executive Order 13175
As required by Executive Order
13175, entitled Consultation and
Coordination with Indian Tribal
Governments (65 FR 22951, November
6, 2000), EPA has determined that this
action does not have tribal implications
because it will not have substantial
direct effects on tribal governments, on
the relationship between the Federal
government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
government and Indian tribes, as
specified in the Order. EPA is not aware
of any tribal governments which are
pesticide registrants, refillers or dealers
storing large quantities of pesticides.
Thus, Executive Order 13175 does not
apply to this action.
G. Executive Order 13045
Executive Order 13045, entitled
Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997),
does not apply to this action because it
is not designated as an economically
significant regulatory action as defined
by Executive Order 12866 (see Unit
XIII.A.). Further, this action does not
establish an environmental standard
that is intended to have a negatively
disproportionate effect on children. To
the contrary, this action will provide
added protection for children from
pesticide risk by ensuring the integrity
of pesticide container design, as well as
secure pesticide storage and disposal.
H. Executive Order 13211
This rule is not subject to Executive
Order 13211, entitled Actions
Concerning Regulations that
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) because it is not likely to have
a significant adverse effect on the
supply, distribution, or use of energy.
I. National Technology Transfer
Advancement Act (NTTAA)
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (NTTAA), 15 U.S.C. 272
note) directs EPA to use voluntary
consensus standards in its regulatory
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47419
activities unless to do so would be
inconsistent with applicable law or
otherwise impractical. Voluntary
consensus standards are technical
standards (e.g., materials specifications,
test methods, sampling procedures,
business practices, etc.) that are
developed or adopted by voluntary
consensus standards bodies. NTTAA
directs EPA to provide Congress,
through OMB, explanations when the
Agency decides not to use available and
applicable voluntary consensus
standards. This action requires
performance standards for containment
structures and residue removal testing
for containers of certain pesticide
formulations, but does not require
specific methods or standards.
Therefore, this action does not impose
any technical standards that would
require Agency consideration of
voluntary consensus standards.
J. Executive Order 12898
This action does not have an adverse
impact on the environmental and health
conditions in low-income and minority
communities. Therefore, under
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994), the Agency has not
considered environmental justicerelated issues. Although not directly
impacting environmental justice-related
concerns, the Agency believes that the
requirements in this rule will assist EPA
and others in reducing potential
exposures associated with the handling,
storage, management and disposal of
pesticide containers covered by the rule.
XIV. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
Agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and the Comptroller General of
the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. This rule is not a
major rule as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 9
Environmental protection, Reporting
and recordkeeping requirements.
List of Subjects in 40 CFR Part 156
Environmental protection, Labeling,
Pesticides and pests.
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List of Subjects in 40 CFR Part 165
PART 9—[AMENDED]
Environmental protection, Packaging
and containers, Containment structures,
Pesticides and pests.
■
Dated: August 3, 2006.
Stephen L. Johnson,
Administrator.
Therefore, 40 CFR chapter I is
amended as follows:
■ 1. Part 9 is amended as follows:
■
6901–6992k, 7401–7671q, 7542, 9601–9657,
11023, 11048.
a. The authority citation for part 9
continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136–136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671,
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
1321, 1326, 1330, 1342, 1344, 1345 (d) and
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971–1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
40 CFR citation
b. In § 9.1 the table is amended by
adding a new center heading entitled
‘‘Pesticide Management and Disposal’’
and an entry for new part 165 after the
center heading and entries for ‘‘State
Registration of Pesticide Products,’’ to
read as follows:
■
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
*
*
*
*
*
*
Pesticide Management and Disposal
*
Part 165 ...........................................................................
*
PART 156—[AMENDED]
2. Part 156 is amended as follows:
a. The authority citation for part 156
continues to read as follows:
■
■
Authority: 7 U.S.C. 136 through 136y.
b. In § 156.10 by adding paragraph
(d)(7), and by revising paragraphs (f)
and (i)(2)(ix) to read as follows:
■
Labeling requirements.
jlentini on PROD1PC65 with RULES2
*
*
*
*
*
(d)* * *
(7) For a pesticide product packaged
in a refillable container, an
appropriately sized area on the label
may be left blank to allow the net
weight or measure of content to be
marked in by the refiller according to 40
CFR 165.65(h) or 165.70(i) prior to
distribution or sale of the pesticide. As
required in paragraph (a)(1)(iii) of this
section, the net contents must be shown
clearly and prominently on the label.
*
*
*
*
*
(f) Producing establishment’s
registration number. The producing
establishment registration number
preceded by the phrase ‘‘EPA Est.’’, of
the final establishment at which the
product was produced may appear in
any suitable location on the label or
immediate container. It must appear on
the wrapper or outside container of the
package if the EPA establishment
registration number on the immediate
container cannot be clearly read through
such wrapper or container. For a
pesticide product packaged in a
refillable container, an appropriately
sized area on the label may be left blank
after the phrase ‘‘EPA Est.’’ to allow the
EPA establishment registration number
to be marked in by the refiller according
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*
OMB Control No.
*
§ 156.10
*
2070–0133
*
*
*
*
*
*
to 40 CFR 165.65(h) or 165.70(i) prior to
distribution or sale of the pesticide.
*
*
*
*
*
(i) * * *
(2)* * *
(ix) Specific directions concerning the
storage, residue removal and disposal of
the pesticide and its container, in
accordance with subpart H of this part
and part 165 of this chapter. These
instructions must be grouped and
appear under the heading, ‘‘Storage and
Disposal.’’ This heading must be set in
type of the same minimum sizes as
required for the child hazard warning.
(See table in § 156.60(b))
*
*
*
*
*
■ c. By adding Subpart H entitled
‘‘Container Labeling’’ to read as follows:
Subpart H—Container Labeling
Sec.
156.140 Identification of container types.
156.144 Residue removal instructions general.
156.146 Residue removal instructions for
nonrefillable containers - rigid
containers with dilutable pesticides.
156.156 Residue removal instructions for
refillable containers.
156.159 Compliance date.
Subpart H—Container Labeling
§ 156.140
Identification of container types.
For products other than plantincorporated protectants, the following
statements, as applicable, must be
placed on the label or container. The
information may be located on any part
of the container except the closure. If
the statements are placed on the
container, they must be durably marked
on the container. Durable marking
includes, but is not limited to etching,
embossing, ink jetting, stamping, heat
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stamping, mechanically attaching a
plate, molding, or marking with durable
ink.
(a) Nonrefillable container. For
nonrefillable containers, the statements
in paragraphs (a)(1) through (a)(4) of this
section are required. If placed on the
label, the statements in paragraphs (a)(1)
through (a)(3) of this section must be
under an appropriate heading under the
heading ‘‘Storage and Disposal.’’ If any
of the statements in paragraphs (a)(1)
through (a)(3) of this section are placed
on the container, an appropriate referral
statement such as ‘‘See container for
recycling [or other descriptive word]
information.’’ must be placed on the
label under the heading ‘‘Storage and
Disposal.’’
(1) Statement identifying a
nonrefillable container. The following
phrase is required: ‘‘Nonrefillable
container.’’
(2) Reuse statement. One of the
following statements is required.
Products with labels that allow
household/residential use must use the
statement in paragraph (a)(2)(i) or
(a)(2)(iii) of this section. All other
products must use the statement in
paragraph (a)(2)(i), (a)(2)(ii), or (a)(2)(iii)
of this section.
(i) ‘‘Do not reuse or refill this
container.’’
(ii) ‘‘Do not reuse this container to
hold materials other than pesticides or
dilute pesticides (rinsate). After
emptying and cleaning, it may be
allowable to temporarily hold rinsate or
other pesticide-related materials in the
container. Contact your state regulatory
agency to determine allowable practices
in your state.’’
(iii) The following statement may be
used if a product is ‘‘ready-to-use’’ and
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its directions for use allow a different
product (that is a similar, but
concentrated formulation) to be poured
into the container and diluted by the
end user: ‘‘Do not reuse or refill this
container unless the directions for use
allow a different (concentrated) product
to be diluted in the container.’’
(3) Recycling or reconditioning
statement. One of the following
statements is required:
(i) ‘‘Offer for recycling if available.’’
(ii) ‘‘Once cleaned, some agricultural
plastic pesticide containers can be taken
to a container collection site or picked
up for recycling. To find the nearest site,
contact your chemical dealer or
manufacturer or contact [a pesticide
container recycling organization] at
[phone number] or [web site]. For
example, this statement could be ‘‘Once
cleaned, some agricultural plastic
pesticide containers can be taken to a
container collection site or picked up
for recycling. To find the nearest site,
contact your chemical dealer or
manufacturer or contact the Ag
Container Recycling Council (ACRC) at
1–877–952–2272 (toll-free) or
www.acrecycle.org.’’
(iii) A recycling statement approved
by EPA and published in an EPA
document, such as a Pesticide
Registration Notice.
(iv) An alternative recycling statement
that has been reviewed and approved by
EPA.
(v) ‘‘Offer for reconditioning if
appropriate.’’
(4) Batch code. A lot number, or other
code used by the registrant or producer
to identify the batch of the pesticide
product which is distributed and sold is
required.
(b) Refillable container. For refillable
containers, one of the following
statements is required. If placed on the
label, it must be under the heading
‘‘Storage and Disposal.’’ If the statement
is placed on the container, an
appropriate referral statement, such as
‘‘Refilling limitations are on the
container.’’ must be placed under the
heading ‘‘Storage and Disposal.’’
(1) ‘‘Refillable Container. Refill this
container with pesticide only. Do not
reuse this container for any other
purpose.’’
(2) ‘‘Refillable Container. Refill this
container with [common chemical
name] only. Do not reuse this container
for any other purpose.’’
§ 156.144
general.
Residue removal instructions -
(a) General. Except as provided by
paragraphs (c) and (d) of this section,
the label of each pesticide product must
include the applicable instructions for
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removing pesticide residues from the
container prior to container disposal
that are specified in §§ 156.146 and
156.156. The residue removal
instructions are required for both
nonrefillable and refillable containers.
(b) Placement of residue removal
statements. All residue removal
instructions must be placed under the
heading ‘‘Storage and Disposal.’’
(c) Exemption for residential/
household use products. Residential/
household use pesticide products are
exempt from the residue removal
instruction requirements in this section
through § 156.156.
(d) Modification. EPA may, on its own
initiative or based on data submitted by
any person, modify or waive the
requirements of this section through
§ 156.156, or permit or require
alternative labeling statements.
§ 156.146 Residue removal instructions for
nonrefillable containers - rigid containers
with dilutable pesticides.
The label of each dilutable (liquid or
solid) pesticide product packaged in a
rigid nonrefillable container must
include the following residue removal
instructions as appropriate.
(a) Timing of the residue removal
procedure. One of the following
statements must immediately precede
the instructions required in paragraph
(b) of this section and must be
consistent with the instructions in
paragraphs (b) and (c) of this section:
(1) ‘‘Clean container promptly after
emptying.’’
(2) ‘‘Triple rinse or pressure rinse
container (or equivalent) promptly after
emptying.’’
(3) ‘‘Triple rinse container (or
equivalent) promptly after emptying.’’
(b) Triple rinse instructions. The label
of each dilutable pesticide product
packaged in rigid nonrefillable
containers must include one of the
following sets of instructions.
(1) For liquid dilutable pesticide
products in containers small enough to
shake, use the following instructions:
‘‘Triple rinse as follows: Empty the
remaining contents into application
equipment or a mix tank and drain for
10 seconds after the flow begins to drip.
Fill the container 1/4 full with water
and recap. Shake for 10 seconds. Pour
rinsate into application equipment or a
mix tank or store rinsate for later use or
disposal. Drain for 10 seconds after the
flow begins to drip. Repeat this
procedure two more times.’’
(2) For solid dilutable pesticide
products in containers small enough to
shake, use the following instructions:
‘‘Triple rinse as follows: Empty the
remaining contents into application
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equipment or a mix tank. Fill the
container 1/4 full with water and recap.
Shake for 10 seconds. Pour rinsate into
application equipment or a mix tank or
store rinsate for later use or disposal.
Drain for 10 seconds after the flow
begins to drip. Repeat this procedure
two more times.’’
(3) For containers that are too large to
shake, use the following instructions:
‘‘Triple rinse as follows: Empty
remaining contents into application
equipment or a mix tank. Fill the
container 1/4 full with water. Replace
and tighten closures. Tip container on
its side and roll it back and forth,
ensuring at least one complete
revolution, for 30 seconds. Stand the
container on its end and tip it back and
forth several times. Turn the container
over onto its other end and tip it back
and forth several times. Empty the
rinsate into application equipment or a
mix tank or store rinsate for later use or
disposal. Repeat this procedure two
more times.’’
(c) Pressure rinse instructions. The
label of each dilutable pesticide product
packaged in rigid nonrefillable
containers may include one of the
following sets of instructions, and one
of them must be used if the statement
in paragraph (a)(2) of this section is
used. If one of these statements is
included on the label, it must
immediately follow the triple rinse
instructions specified in paragraph (b)
of this section.
(1) For liquid dilutable pesticide
products, use the following label
instruction: ‘‘Pressure rinse as follows:
Empty the remaining contents into
application equipment or a mix tank
and continue to drain for 10 seconds
after the flow begins to drip. Hold
container upside down over application
equipment or mix tank or collect rinsate
for later use or disposal. Insert pressure
rinsing nozzle in the side of the
container, and rinse at about 40 PSI for
at least 30 seconds. Drain for 10 seconds
after the flow begins to drip.’’
(2) For solid dilutable pesticide
products, use the following label
instruction: ‘‘Pressure rinse as follows:
Empty the remaining contents into
application equipment or a mix tank.
Hold container upside down over
application equipment or mix tank or
collect rinsate for later use or disposal.
Insert pressure rinsing nozzle in the side
of the container, and rinse at about 40
PSI for at least 30 seconds. Drain for 10
seconds after the flow begins to drip.’’
(d) Non-water diluent. (1) A registrant
who wishes to require users to clean a
container with a diluent other than
water (e.g., solvents) must submit to
EPA a written request to modify the
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residue removal instructions of this
section. The registrant may not
distribute or sell the pesticide with the
modified residue removal instructions
until EPA approves the request in
writing.
(2) The registrant must indicate why
a non-water diluent is necessary for
efficient residue removal, and must
propose residue removal instructions
and disposal instructions that are
appropriate for the characteristics and
formulation of the pesticide product and
non-water diluent. The proposed
residue removal instructions must
identify the diluent. If the Directions for
Use permit the application of a mixture
of the pesticide and the non-water
diluent, the instructions may allow the
rinsate to be added to the application
equipment or mix tank. If the Directions
for Use do not identify the non-water
diluent as an allowable addition to the
pesticide, the instructions must require
collection and storage of the rinsate in
a rinsate collection system.
(3) EPA may approve the request if
EPA finds that the proposed
instructions are necessary and
appropriate.
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§ 156.156 Residue removal instructions for
refillable containers.
The label of each pesticide product
packaged in a refillable container must
include the residue removal instructions
in this section. Instructions must be
given for all pesticide products that are
distributed or sold in refillable
containers, including those that do not
require dilution prior to application.
(a) Timing of the residue removal
procedure. One of the following
statements must immediately precede
the instructions required in paragraph
(b) of this section and must be
consistent with the instructions in
paragraph (b) of this section:
(1) ‘‘Cleaning the container before
final disposal is the responsibility of the
person disposing of the container.
Cleaning before refilling is the
responsibility of the refiller.’’
(2) ‘‘Pressure rinsing the container
before final disposal is the
responsibility of the person disposing of
the container. Cleaning before refilling
is the responsibility of the refiller.’’
(b) Residue removal instructions prior
to container disposal. (1) Instructions
for cleaning each refillable container
prior to disposal are required. The
residue removal instructions must be
appropriate for the characteristics and
formulation of the pesticide product and
must be adequate to protect human
health and the environment.
(2) Subject to meeting the standard in
paragraph (b)(1) of this section, the
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statement on residue removal
instructions could include any one of
the following:
(i) The refilling residue removal
procedure developed by the registrant
for the pesticide product.
(ii) Standard industry practices for
cleaning refillable containers.
(iii) For pesticides that require
dilution prior to application, the
following statement: ‘‘To clean the
container before final disposal, empty
the remaining contents from this
container into application equipment or
a mix tank. Fill the container about 10
percent full with water. Agitate
vigorously or recirculate water with the
pump for 2 minutes. Pour or pump
rinsate into application equipment or
rinsate collection system. Repeat this
rinsing procedure two more times.’’
(iv) Any other statement the registrant
considers appropriate.
§ 156.159
Compliance date.
As of August 17, 2009, all pesticide
products distributed or sold by a
registrant must have labels that comply
with §§ 156.10(d)(7), 156.10(f),
156.10(i)(2)(ix), 156.140, 156.144,
156.146, and 156.156.
■ 3. By adding a new part 165 to read
as follows:
Part 165—Pesticide Management and
Disposal
165.67 Registrants who distribute or sell
pesticide products to refillers for
repackaging.
165.70 Refillers who are not registrants.
165.71–165.79 [Reserved]
Subpart E—Standards for Pesticide
Containment Structures
165.80 General provisions.
165.81 Scope of stationary pesticide
containers included.
165.82 Scope of pesticide dispensing areas
included.
165.83 Definition of new and existing
structures.
165.85 Design and capacity requirements
for new structures.
165.87 Design and capacity requirements
for existing structures.
165.90 Operational, inspection and
maintenance requirements for all new
and existing containment structures.
165.92 What if I need both a containment
pad and a secondary containment unit?
165.95 What recordkeeping do I have to do
as a facility owner or operator?
165.97 States with existing containment
programs.
Authority: 7 U.S.C. 136 through 136y.
Subpart A—General
§ 165.1
§ 165.3
Sec.
Subpart A—General
165.1 Scope.
165.3 Definitions.
165.4–165.19 [Reserved]
Subpart B—Nonrefillable Container
Standards: Container Design and Residue
Removal
165.20 General provisions.
165.23 Scope of pesticide products
included.
165.25 Nonrefillable container standards.
165.27 Reporting and recordkeeping.
165.28–165.39 [Reserved]
Subpart C—Refillable Container Standards:
Container Design
165.40 General provisions.
165.43 Scope of pesticide products
included.
165.45 Refillable container standards.
165.47 What information must I report
about my refillable containers?
165.48–165.59 [Reserved]
Subpart D—Standards for Repackaging
Pesticide Products into Refillable
Containers
165.60 General provisions.
165.63 Scope of pesticide products
included.
165.65 Registrants who distribute or sell
pesticide products in refillable
containers.
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Scope.
The Part 165 regulations establish
standards and requirements for
pesticide containers, repackaging
pesticides, and pesticide containment
structures.
Definitions.
Act means the Federal Insecticide,
Fungicide, and Rodenticide Act.
Agricultural pesticide means any
pesticide product labeled for use in a
nursery or greenhouse or for use in the
production of any agricultural
commodity, including any plant, plant
part, animal, or animal product
produced by persons (including farmers,
ranchers, vineyardists, plant
propagators, Christmas tree growers,
aquaculturalists, horticulturists,
orchardists, foresters, or other
comparable persons) primarily for sale,
consumption, propagation or other use
by man or animals.
Appurtenance means any equipment
or device which is used for the purpose
of transferring a pesticide from a
stationary pesticide container or to any
refillable container, including but not
limited to, hoses, fittings, plumbing,
valves, gauges, pumps and metering
devices.
Container means any package, can,
bottle, bag, barrel, drum, tank, or other
containing-device (excluding any
application tanks) used to enclose a
pesticide. Containers that are used to
sell or distribute a pesticide product and
that also function in applying the
product (such as spray bottles, aerosol
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cans and containers that become part of
a direct injection system) are considered
to be containers for the purposes of this
part.
Containment pad means any structure
that is designed and constructed to
intercept and contain pesticides,
rinsates, and equipment wash water at
a pesticide dispensing area.
Containment structure means either a
secondary containment unit or a
containment pad.
Custom blending means the service of
mixing pesticides to a customer’s
specifications, usually a pesticide(s)fertilizer(s), pesticide-pesticide, or a
pesticide-animal feed mixture, when:
(1) The blend is prepared to the order
of the customer and is not held in
inventory by the blender;
(2) The blend is to be used on the
customer’s property (including leased or
rented property);
(3) The pesticide(s) used in the blend
bears end-use labeling directions which
do not prohibit use of the product in
such a blend;
(4) The blend is prepared from
registered pesticides; and
(5) The blend is delivered to the enduser along with a copy of the end-use
labeling of each pesticide used in the
blend and a statement specifying the
composition of the mixture.
Dry pesticide means any pesticide
that is in solid form and that has not
been combined with liquids; this
includes formulations such as dusts,
wettable powders, dry flowable
powders, granules, and dry baits.
Establishment means any site where a
pesticidal product, active ingredient, or
device is produced, regardless of
whether such site is independently
owned or operated, and regardless of
whether such site is domestic and
producing a pesticidal product for
export only, or whether the site is
foreign and producing any pesticidal
product for import into the United
States.
Facility means all buildings,
equipment, structures, and other
stationary items which are located on a
single site or on contiguous or adjacent
sites and which are owned or operated
by the same person (or by any person
who controls, who is controlled by, or
who is under common control with
such person).
Flowable concentrate means a stable
suspension of active ingredients in a
liquid intended for dilution with water
before use.
Nonrefillable container means a
container that is not a refillable
container and that is designed and
constructed for one time containment of
a pesticide for sale or distribution.
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Reconditioned containers are
considered to be nonrefillable
containers.
One-way valve means a valve that is
designed and constructed to allow
virtually unrestricted flow in one
direction and no flow in the opposite
direction, thus allowing the withdrawal
of material from, but not the
introduction of material into, a
container.
Operator means any person in control
of, or having responsibility for, the daily
operation of a facility at which a
containment structure is located.
Owner means any person who owns a
facility at which a containment
structure is required.
Pesticide compatible means, as
applied to containers, that the container
construction materials will not
chemically react with the formulation.
A container is not compatible with the
formulation if, for example, the
formulation:
(1) Is corrosive to the container;
(2) Causes softening, premature aging,
or embrittlement of the container;
(3) Otherwise causes the container to
weaken or to create the risk of
discharge;
(4) Reacts in a significant chemical,
electrolytic, or galvanic manner with the
container, or
(5) Interacts in a way, such as the
active ingredient permeating the
container wall, that would cause the
formulation to differ from its
composition as described in the
statement required in connection with
its registration under FIFRA section 3.
Pesticide compatible means, as
applied to secondary containment, that
the containment construction materials
are able to withstand anticipated
exposure to stored or transferred
materials without losing the capacity to
provide the required secondary
containment of the same or other
materials within the containment area.
Pesticide dispensing area means an
area in which pesticide is transferred
out of or into a container.
Portable pesticide container means a
refillable container that is not a
stationary pesticide container.
Pressure rinse means the flushing of
the container to remove pesticide
residue by using a pressure method with
a pressure of at least 40 PSI.
Produce means to manufacture,
prepare, propagate, compound, or
process any pesticide, including any
pesticide produced pursuant to section
5 of the Act, and any active ingredient
or device, or to package, repackage,
label, relabel, or otherwise change the
container of any pesticide or device.
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Producer means any person, as
defined by the Act, who produces any
pesticide, active ingredient, or device
(including packaging, repackaging,
labeling and relabeling).
Refillable container means a container
that is intended to be filled with
pesticide more than once for sale or
distribution.
Refiller means a person who engages
in the activity of repackaging pesticide
product into refillable containers. This
could include a registrant or a person
operating under contract to a registrant.
Refilling establishment means an
establishment where the activity of
repackaging pesticide product into
refillable containers occurs.
Repackage means, for the purposes of
this part, to transfer a pesticide
formulation from one container to
another without a change in the
composition of the formulation, the
labeling content, or the product’s EPA
registration number, for sale or
distribution.
Rinsate means the liquid produced
from the rinsing of the interior of any
equipment or container that has come in
direct contact with any pesticide.
Runoff means surface water leaving
the target site.
Secondary containment unit means
any structure, including rigid diking,
that is designed and constructed to
intercept and contain pesticide spills
and leaks and to prevent runoff and
leaching from stationary pesticide
containers.
Stationary pesticide container means
a refillable container that is fixed at a
single facility or establishment or, if not
fixed, remains at the facility or
establishment for at least 30 consecutive
days, and that holds pesticide during
the entire time.
Tamper-evident device means a
device which can be visually inspected
to determine if a container has been
opened.
Transport vehicle means a cargocarrying vehicle such as an automobile,
van, tractor, truck, semitrailer, tank car
or rail car used for the transportation of
cargo by any mode.
Triple rinse means the flushing of the
container three times to remove
pesticide residue by using a nonpressurized method.
Washwater means the liquid
produced from the rinsing of the
exterior of any equipment or containers
that have or may have come in direct
contact with any pesticide or system
maintenance compound.
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§§ 165.4–165.19
[Reserved]
Subpart B—Nonrefillable Container
Standards: Container Design and
Residue Removal
§ 165.20
General provisions.
(a) What is the purpose of the
regulations in this subpart? The
regulations in this subpart establish
design and construction requirements
for nonrefillable containers used for the
distribution or sale of some pesticide
products.
(b) Do I have to comply with the
regulations in this subpart? You must
comply with the regulations in this
subpart if you are a registrant who
distributes or sells a pesticide product
in nonrefillable containers. If your
pesticide product is subject to the
regulations in this subpart as set out in
§ 165.23, your pesticide product must be
distributed or sold in a nonrefillable
container that meets the standards of
these regulations.
(c) When do I have to comply? As of
August 17, 2009, all pesticide products
distributed or sold by you in
nonrefillable containers must be
distributed or sold in compliance with
these regulations.
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§ 165.23 Scope of pesticide products
included.
(a) Are manufacturing use products
subject to the regulations in this
subpart? No, the regulations in this
subpart do not apply to manufacturing
use products, as defined in § 158.153(h)
of this chapter.
(b) Are plant-incorporated protectants
subject to the regulations in this
subpart? No, the regulations in this
subpart do not apply to plantincorporated protectants, as defined in
§ 174.3 of this chapter.
(c) Which antimicrobial pesticide
products are not subject to the
regulations in this subpart? The
regulations in this subpart do not apply
to a pesticide product if it satisfies all
of the following conditions:
(1) The pesticide product meets one of
the following two criteria:
(i) The pesticide product is an
antimicrobial pesticide as defined in
FIFRA section 2(mm); or
(ii) The pesticide product: (A) Is
intended to: disinfect, sanitize, reduce
or mitigate growth or development of
microbiological organisms; or protect
inanimate objects, industrial processes
or systems, surfaces, water, or other
chemical substances from
contamination, fouling, or deterioration
caused by bacteria, viruses, fungi,
protozoa, algae, or slime; and
(B) In the intended use is subject to
a tolerance under section 408 of the
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Federal Food, Drug, and Cosmetic Act
or a food additive regulation under
section 409 of such Act.
(2) The labeling of the pesticide
product includes directions for use on a
site in at least one of the following
antimicrobial product use categories:
food handling/storage establishments
premises and equipment; commercial,
institutional, and industrial premises
and equipment; residential and public
access premises; medical premises and
equipment; human drinking water
systems; materials preservatives;
industrial processes and water systems;
antifouling coatings; wood
preservatives; or swimming pools.
(3) The pesticide product is not a
hazardous waste as set out in part 261
of this chapter when the pesticide
product is intended to be disposed.
(4) EPA has not specifically
determined that the pesticide product
must be subject to the regulations in this
subpart to prevent an unreasonable
adverse effect on the environment
according to the provisions of paragraph
(d) of this section.
(d) How will EPA determine if an
‘‘antimicrobial’’ pesticide product
otherwise exempted must be subject to
the regulations in this subpart to
prevent an unreasonable adverse effect
on the environment? (1) EPA may
determine that an antimicrobial
pesticide product otherwise exempted
by paragraph (c) of this section must be
subject to the nonrefillable container
regulations in this subpart to prevent an
unreasonable adverse effect on the
environment if all of the following
conditions exist:
(i) EPA obtains information, data or
other evidence of a problem with the
containers of a certain pesticide product
or related group of products.
(ii) The information, data or other
evidence is reliable and factual.
(iii) The problem causes or could
reasonably be expected to cause an
unreasonable adverse effect on the
environment.
(iv) Complying with the container
regulations could reasonably be
expected to eliminate the problem.
(2) If EPA determines that an
antimicrobial pesticide product
otherwise exempted by paragraph (c) of
this section must be subject to the
nonrefillable container regulations in
this subpart to prevent an unreasonable
adverse effect on the environment, EPA
may require, by rule, that the product be
distributed or sold in nonrefillable
containers that comply with all or some
of the requirements in this subpart.
Alternatively, EPA may notify the
applicant or registrant of its intent to
make such a determination. After
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allowing the applicant or registrant a
reasonable amount of time to reply, EPA
may require, by notification and as a
condition of registration, that the
product be distributed or sold in
nonrefillable containers that comply
with all or some of the requirements in
this subpart. For the purpose of the
previous sentence, 60 days would be a
reasonable amount of time to reply,
although EPA may, in its discretion,
provide more time. EPA may deny
registration or initiate cancellation
proceedings if the registrant fails to
comply with the nonrefillable container
regulations within the time frames
established by EPA in the rule or in its
notification.
(e) What other pesticide products are
subject to the regulations in this
subpart? (1) Except for manufacturing
use products, plant-incorporated
protectants, and antimicrobial products
that are exempt under paragraph (c) of
this section, all of the regulations in this
subpart apply to a pesticide product if
it satisfies at least one of the following
criteria:
(i) The pesticide product meets the
criteria of Toxicity Category I as set out
in § 156.62 of this chapter.
(ii) The pesticide product meets the
criteria of Toxicity Category II as set out
in § 156.62 of this chapter.
(iii) The pesticide product is
classified for restricted use as set out in
§§ 152.160 - 152.175 of this chapter.
(2) Except for manufacturing use
products, plant-incorporated
protectants, antimicrobial products that
are exempt under (c) of this section, and
other pesticide products that are
regulated under paragraph (e)(1) of this
section, a pesticide product must be
packaged in compliance with 49 CFR
173.24. If the pesticide product meets
the definition of a hazardous material in
49 CFR 171.8, the Department of
Transportation requires it to be
packaged according to 49 CFR parts
171–180.
(f) What does ‘‘pesticide product’’ or
‘‘pesticide’’ mean in the rest of this
subpart? In §§ 165.25 through 165.27,
the term ‘‘pesticide product’’ or
‘‘pesticide’’ refers only to a pesticide
product or a pesticide that is subject to
the regulations in this subpart as
described in paragraphs (a) through (e)
of this section.
§ 165.25
Nonrefillable container standards.
(a) What Department of
Transportation (DOT) standards do my
nonrefillable containers have to meet
under this part if my pesticide product
is not a DOT hazardous material? A
pesticide product that does not meet the
definition of a hazardous material in 49
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CFR 171.8 must be packaged in a
nonrefillable container that is designed,
constructed, and marked to comply with
the requirements of 49 CFR 173.24,
173.24a, 173.24b, 173.28, 173.155,
173.203, 173.213, 173.240(c),
173.240(d), 173.241(c), 173.241(d), part
178, and part 180 that are applicable to
a Packing Group III material.
(b) What DOT standards do my
nonrefillable containers have to meet
under this part if my pesticide product
is a DOT hazardous material? (1) If your
pesticide product meets the definition
of a hazardous material in 49 CFR 171.8,
the DOT requires your pesticide product
to be packaged according to 49 CFR
parts 171–180.
(2) For the purposes of these
regulations, a pesticide product that
meets the definition of a hazardous
material in 49 CFR 171.8 must be
packaged in a nonrefillable container
that is designed, constructed, and
marked to comply with the
requirements of 49 CFR parts 171–180.
(c) What will EPA do if DOT proposes
to change any of the cross-referenced
regulations? If the DOT proposes to
change any of the regulations that are
incorporated in paragraphs (a) and (b) of
this section, EPA will provide notice of
the proposed changes and an
opportunity to comment in the Federal
Register. Following notice and
comment, EPA will take final action
regarding whether or not to revise its
rules, and the extent to which any such
revision will correspond with revised
DOT regulations.
(d) What standards for closures do my
nonrefillable containers have to meet? If
your nonrefillable container is a rigid
container with a capacity equal to or
greater than 3.0 liters (0.79 gallons), if
the container is not an aerosol container
or a pressurized container, and if the
container is used to distribute or sell a
liquid agricultural pesticide, each
nonrefillable container must have at
least one of the following standard
closures:
(1) Bung, 2 inch pipe size (2.375
inches in diameter), external threading,
11.5 threads per inch, National Pipe
Straight (NPS) standard.
(2) Bung, 2 inch pipe size (2.375
inches in diameter), external threading,
5 threads per inch, buttress threads.
(3) Screw cap, 63 millimeters, at least
one thread revolution at 6 threads per
inch.
(4) Screw cap, 38 millimeters, at least
one thread revolution at 6 threads per
inch. The cap may fit on a separate rigid
spout or on a flexible pull-out plastic
spout.
(e) What standards for dispensing do
my nonrefillable containers have to
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meet? If your nonrefillable container has
a capacity of 5 gallons (18.9 liters) or
less, if the container is not an aerosol
container, a pressurized container, or a
spray bottle, and if the container holds
a liquid pesticide, your nonrefillable
container must do both of the following:
(1) Allow the contents of the
nonrefillable container to pour in a
continuous, coherent stream.
(2) Allow the contents of the
nonrefillable container to be poured
with a minimum amount of dripping
down the outside of the container.
(f) What standards for residue
removal do my nonrefillable containers
have to meet? Each nonrefillable
container and pesticide formulation
combination must meet the applicable
residue removal standard of this section.
(1) If the nonrefillable container is
rigid and has a capacity less than or
equal to 5 gallons (18.9 liters) for liquid
formulations or 50 pounds (22.7
kilograms) for solid formulations and if
the pesticide product’s labeling allows
or requires the pesticide product to be
mixed with a liquid diluent prior to
application (that is, if the pesticide is
dilutable), each container/formulation
combination must be capable of
attaining at least 99.99 percent removal
of each active ingredient when tested
using the EPA test procedure ‘‘Rinsing
Procedures for Dilutable Pesticide
Products in Rigid Containers.’’
(2) The test must be conducted only
if the pesticide product is a flowable
concentrate or if EPA specifically
requests the records on a case by case
basis.
(3) For the rigid container/dilutable
product standard in paragraph (f)(1) of
this section, percent removal represents
the percent of the original concentration
of the active ingredient in the pesticide
product when compared to the
concentration of that active ingredient
in the fourth rinse. Percent removal is
calculated by the formula:
percent removal = [1.0 - RR] x 100.0, where
RR = rinsate ratio = Active ingredient
concentration in fourth rinsate/Original
concentration of active ingredient in the
product
(g) Can I obtain a waiver from or a
modification to any of the nonrefillable
container standards? Yes, it is possible
for you to obtain a waiver from or a
modification to the nonrefillable
container standards, as follows:
(1) EPA may waive or modify the
requirements of paragraph (a) of this
section regarding the DOT standards for
pesticide products that are not DOT
hazardous materials if EPA determines
that an alternative (partial or modified)
set of standards or pre-existing
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requirements achieves a level of safety
that is at least equal to that specified in
the requirements of paragraph (a) of this
section.
(2) EPA may waive or modify the
requirements of paragraph (b) of this
section regarding the DOT standards for
pesticide products that are DOT
hazardous materials if EPA determines
that an alternative (partial or modified)
set of standards or pre-existing
requirements achieves a level of safety
that is at least equal to that specified in
the requirements of paragraph (b) of this
section. EPA will modify or waive the
requirements of paragraph (b) of this
section only after consulting with DOT
to ensure consistency with DOT
regulations and exemptions.
(3) EPA may approve a non-standard
closure (that is, a closure not listed in
paragraph (d) of this section) if EPA
determines that both of the following
conditions are satisfied:
(i) The non-standard closure is
necessary for the proper mixing,
loading, or application of the pesticide
product.
(ii) The non-standard closure offers
exposure protection to handlers during
mixing and loading that is the same or
greater than that provided by the
standard closures.
(4) EPA may waive or modify the
container dispensing capability
standards in paragraph (e) of this
section if EPA determines that at least
one of the following conditions is
satisfied:
(i) The product is typically removed
from the container by a method other
than pouring.
(ii) Compliance with the container
dispensing capability standards would
increase exposure to the pesticide
container handler.
(5) EPA may waive or modify the
requirements of paragraph (f) of this
section regarding the residue removal
standard if EPA determines that both of
the following conditions are satisfied:
(i) The residue remaining in the
container would not cause an
unreasonable adverse effect on the
environment; and
(ii) The product offers significant
benefits and cannot be economically
reformulated or repackaged.
(h) How do I obtain a waiver from or
a modification to any of the
nonrefillable container standards? To
obtain a waiver from or a modification
to any of the nonrefillable container
standards, you must submit a written
request for a waiver or a modification to
the EPA to the following address: Office
of Pesticide Programs (7504P); U.S.
Environmental Protection Agency; Ariel
Rios Building; 1200 Pennsylvania
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Avenue, N.W., Washington, DC 20460.
You cannot distribute or sell the
pesticide product in a nonrefillable
container that does not comply with all
of the nonrefillable container standards
unless and until EPA approves the
request for the waiver or modification in
writing. You must include two copies of
the following information (which may
be part of an application for registration
or amended registration) with your
written request:
(1) The name and address of the
registrant; the date; and the name, title,
signature, and phone number of the
company official making the request.
(2) The name and EPA registration
number of the pesticide product for
which the waiver or modification is
requested.
(3) A statement specifying the
requirement or requirements from
which you are requesting a waiver or a
modification.
(4) A description of the nonrefillable
container or containers for which the
waiver or modification is requested.
(5) Documentation or justification to
demonstrate that the applicable waiver
or modification criteria in paragraph (g)
of this section are satisfied.
jlentini on PROD1PC65 with RULES2
§ 165.27
Reporting and recordkeeping.
(a) What information must I report
about my nonrefillable containers? You
are not required to report to EPA with
information about your nonrefillable
containers under the regulations in this
subpart. You should refer to the
reporting standards in part 159 of this
chapter to determine if information on
container failures or other incidents
involving pesticide containers must be
reported to EPA under FIFRA section
6(a)(2) (7 U.S.C. 136d(a)(2)).
(b) What recordkeeping do I have to
do for my nonrefillable containers? For
each pesticide product that is subject to
§ 165.25 - 165.27 and is distributed or
sold in nonrefillable containers, you
must maintain the records listed in this
section for as long as a nonrefillable
container is used to distribute or sell the
pesticide product and for 3 years after
that. You must furnish these records for
inspection and copying upon request by
an employee of EPA or any entity
designated by EPA, such as a State,
another political subdivision or a Tribe.
You must keep the following records:
(1) The name and EPA registration
number of the pesticide product.
(2) A description of the nonrefillable
container(s) in which the pesticide
product is distributed or sold.
(3) At least one of the following
records to document compliance with
the requirement for closures in
§ 165.25(d) for each nonrefillable
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container used to distribute or sell the
pesticide product that must comply
with § 165.25(d):
(i) A letter or document from the
container supplier that describes the
closure.
(ii) A specification about the closure
in the contract between the registrant or
applicant and the container supplier.
(iii) A copy of EPA’s approval of any
non-standard closure.
(4) At least one of the following
records pertaining to the container
dispensing capability requirements in
§ 165.25(e) for each nonrefillable
container used to distribute or sell the
pesticide product that must comply
with § 165.25(e):
(i) Test data or documentation
demonstrating that the nonrefillable
container meets the standards in
§ 165.25(e) when it contains the
pesticide product.
(ii) Test data or documentation
demonstrating that a different
nonrefillable container meets the
standards in § 165.25(e) when it
contains the pesticide product or even
a different pesticide product and a
written explanation of why such data or
documentation demonstrates that the
container meets the standards in
§ 165.25(e) for the pesticide product.
(5) At least one of the following
records pertaining to the nonrefillable
container residue removal requirement
in § 165.25(f) if the pesticide product is
a flowable concentrate or if EPA
specifically requests the records on a
case by case basis:
(i) Test data showing that the
nonrefillable container and pesticide
formulation meet the standard in
§ 165.25(f) .
(ii) Test data showing that a different
nonrefillable container with the same or
a different pesticide formulation meets
the standard in § 165.25(f), together with
a written explanation of why such data
demonstrate that the nonrefillable
container and pesticide formulation
meet the standard in § 165.25(f).
§§ 165.28–165.39
[Reserved]
Subpart C—Refillable Container
Standards: Container Design
§ 165.40
General provisions.
(a) What is the purpose of the
regulations in this subpart? The
regulations in this subpart establish
design and construction requirements
for refillable containers used for the
distribution or sale of some pesticide
products.
(b) Do I have to comply with the
regulations in this subpart? (1) You
must comply with all of the regulations
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in this subpart if you are a registrant
who distributes or sells a pesticide
product in refillable containers. If your
pesticide product is subject to the
regulations in this subpart as set out in
§ 165.43, your pesticide product must be
distributed or sold in a refillable
container that meets the standards of
these regulations. This includes your
pesticide products that are repackaged
according to subpart D of this part.
(2) You must comply with the
regulations in § 165.45(f) for stationary
pesticide containers if you are a refiller
of a pesticide product and you are not
the registrant of the pesticide product. If
the pesticide product is subject to the
regulations in this subpart as set out in
§ 165.43, the stationary pesticide
containers used to distribute or sell the
product must meet the standards of
§ 165.45(f).
(c) When do I have to comply? As of
August 16, 2011, all pesticide products
distributed or sold by you in refillable
containers must be distributed or sold in
compliance with these regulations.
§ 165.43 Scope of pesticide products
included.
(a) Are manufacturing use products
subject to the regulations in this
subpart? No, the regulations in this
subpart do not apply to manufacturing
use products, as defined in § 158.153(h)
of this chapter.
(b) Are plant-incorporated protectants
subject to the regulations in this
subpart? No, the regulations in this
subpart do not apply to plantincorporated protectants, as defined in
§ 174.3 of this chapter.
(c) Which ‘‘antimicrobial’’ pesticide
products are not subject to the
regulations in this subpart? The
regulations in this subpart do not apply
to a pesticide product if it satisfies all
of the following conditions:
(1) The pesticide product meets one of
the following two criteria:
(i) The pesticide product is an
antimicrobial pesticide as defined in
FIFRA section 2(mm); or
(ii) The pesticide product: (A) Is
intended to: disinfect, sanitize, reduce
or mitigate growth or development of
microbiological organisms; or protect
inanimate objects, industrial processes
or systems, surfaces, water, or other
chemical substances from
contamination, fouling, or deterioration
caused by bacteria, viruses, fungi,
protozoa, algae, or slime; and
(B) In the intended use is subject to
a tolerance under section 408 of the
Federal Food, Drug, and Cosmetic Act
or a food additive regulation under
section 409 of such Act.
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(2) The labeling of the pesticide
product includes directions for use on a
site in at least one of the following
antimicrobial product use categories:
food handling/storage establishments
premises and equipment; commercial,
institutional, and industrial premises
and equipment; residential and public
access premises; medical premises and
equipment; human drinking water
systems; materials preservatives;
industrial processes and water systems;
antifouling coatings; wood
preservatives; or swimming pools.
(3) The pesticide product is not a
hazardous waste as set out in part 261
of this chapter when the pesticide
product is intended to be disposed.
(4) EPA has not specifically
determined that the pesticide product
must be subject to the regulations in this
subpart to prevent an unreasonable
adverse effect on the environment
according to the provisions of paragraph
(e) of this section.
(d) Which requirements must an
‘‘antimicrobial’’ swimming pool product
comply with if it is not exempt from
these regulations? An antimicrobial
swimming pool product that is not
exempt by paragraph (a), (b), or (c) of
this section must comply with all of the
regulations in this subpart except
§ 165.45(d) regarding marking and
§ 165.45(e) regarding openings. For the
purposes of this subpart, an
antimicrobial swimming pool product is
a pesticide product that satisfies both of
the following conditions:
(1) The pesticide product is intended
to: disinfect, sanitize, reduce or mitigate
growth or development of
microbiological organisms; or protect
inanimate objects, industrial processes
or systems, surfaces, water, or other
chemical substances from
contamination, fouling, or deterioration
caused by bacteria, viruses, fungi,
protozoa, algae, or slime.
(2) The labeling of the pesticide
product includes directions for use on
only a site or sites in the antimicrobial
product use category of swimming
pools.
(e) How will EPA determine if an
‘‘antimicrobial’’ pesticide product
otherwise exempted must be subject to
the regulations in this subpart to
prevent an unreasonable adverse effect
on the environment? (1) EPA may
determine that an antimicrobial
pesticide product otherwise exempted
by paragraph (c) of this section must be
subject to the refillable container
regulations in this subpart to prevent an
unreasonable adverse effect on the
environment if all of the following
conditions exist:
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(i) EPA obtains information, data or
other evidence of a problem with the
containers of a certain pesticide product
or related group of products.
(ii) The information, data or other
evidence is reliable and factual.
(iii) The problem causes or could
reasonably be expected to cause an
unreasonable adverse effect on the
environment.
(iv) Complying with the container
regulations could reasonably be
expected to eliminate the problem.
(2) If EPA determines that an
antimicrobial pesticide product
otherwise exempted by paragraph (c) of
this section must be subject to the
refillable container regulations in this
subpart to prevent an unreasonable
adverse effect on the environment, EPA
may require, by rule, that the product be
distributed or sold in refillable
containers that comply with all or some
of the requirements in this subpart.
Alternatively, EPA may notify the
applicant or registrant of its intent to
make such a determination. After
allowing the applicant or registrant a
reasonable amount of time to reply, EPA
may require, by notification and as a
condition of registration, that the
product be distributed or sold in
refillable containers that comply with
all or some of the requirements in this
subpart. For the purpose of the previous
sentence, 60 days would be a reasonable
amount of time to reply, although EPA
may, in its discretion, provide more
time. EPA may deny registration or
initiate cancellation proceedings if the
registrant fails to comply with the
refillable container regulations within
the time frames established by EPA in
the rule or in its notification.
(f) What other pesticide products are
subject to the regulations in this
subpart? The regulations in this subpart
apply to all pesticide products other
than manufacturing use products, plantincorporated protectants, and
antimicrobial products that are exempt
by paragraph (c) of this section.
Antimicrobial products covered under
by paragraph (d) of this section are
subject to the regulations indicated in
that section.
(g) What does ‘‘pesticide product’’ or
‘‘pesticide’’ mean in the rest of this
subpart? In §§ 165.43(h) through 165.47,
the term ‘‘pesticide product’’ or
‘‘pesticide’’ refers only to a pesticide
product or a pesticide that is subject to
the regulations in this subpart as
described in paragraphs (a) through(f) of
this section.
(h) Are there any other exceptions? (1)
The regulations in this subpart do not
apply to transport vehicles that contain
pesticide in pesticide-holding tanks that
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are an integral part of the transport
vehicle and that are the primary
containment for the pesticide.
(2) The regulations in this subpart do
not apply to containers that hold
pesticides that are gaseous at
atmospheric temperature and pressure.
§ 165.45
Refillable container standards.
(a) What Department of
Transportation (DOT) standards do my
refillable containers have to meet under
this part if my pesticide product is not
a DOT hazardous material? (1) A
pesticide product that does not meet the
definition of a hazardous material in 49
CFR 171.8 must be packaged in a
refillable container that is designed,
constructed, and marked to comply with
the requirements of 49 CFR 173.24,
173.24a, 173.24b, 173.28, 173.155,
173.203, 173.213, 173.240(c),
173.240(d), 173.241(c), 173.241(d), part
178, and part 180 that are applicable to
a Packing Group III material.
(2) A refiller is not required to comply
with 49 CFR 173.28(b)(2) for pesticide
products that are not DOT hazardous
materials if the refillable container to be
reused complies with the refillable
container regulations in this subpart and
the refilling is done in compliance with
the repackaging regulations in subpart D
of this part.
(b) What DOT standards do my
refillable containers have to meet under
this part if my pesticide product is a
DOT hazardous material? (1) If your
pesticide product meets the definition
of a hazardous material in 49 CFR 171.8,
the DOT requires your pesticide product
to be packaged according to 49 CFR
parts 171–180.
(2) For the purposes of these
regulations, a pesticide product that
meets the definition of a hazardous
material in 49 CFR 171.8 must be
packaged in a refillable container that is
designed, constructed, and marked to
comply with the requirements of 49 CFR
parts 171–180.
(c) What will EPA do if DOT proposes
to change any of the cross-referenced
regulations? If the DOT proposes to
change any of the regulations that are
incorporated in paragraphs (a) and (b) of
this section, EPA will provide notice of
the proposed changes and an
opportunity to comment in the Federal
Register. Following notice and
comment, EPA will take final action
regarding whether or not to revise its
rules, and the extent to which any such
revision will correspond with revised
DOT regulations.
(d) What standards for marking do my
refillable containers have to meet? Each
refillable container must be marked in a
durable and clearly visible manner with
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a serial number or other identifying
code that will distinguish the individual
container from all other containers.
Durable marking includes, but is not
limited to, etching, embossing, ink
jetting, stamping, heat stamping,
mechanically attaching a plate, molding,
and marking with durable ink. The
serial number or other identifying code
must be located on the outside part of
the container except on a closure.
Placement on the label or labeling is not
sufficient unless the label is an integral,
permanent part of or permanently
stamped on the container.
(e) What standards for openings do
my refillable containers have to meet? If
your refillable container is a portable
pesticide container that is designed to
hold liquid pesticide formulations and
is not a cylinder that complies with the
DOT Hazardous Materials Regulations,
each opening of the container other than
a vent must have a one-way valve, a
tamper-evident device or both. A oneway valve may be located in a device or
system separate from the container if the
device or system is the only reasonably
foreseeable way to withdraw pesticide
from the container. A vent must be
designed to minimize the amount of
material that could be introduced into
the container through it.
(f) What standards do my stationary
pesticide containers have to meet? If a
stationary pesticide container designed
to hold undivided quantities of
pesticides equal to greater than 500
gallons (1,890 liters) of liquid pesticide
or equal to or greater than 4,000 pounds
(1,818 kilograms) of dry pesticide is
located at the refilling establishment of
a refiller operating under written
contract to you, the stationary pesticide
container must meet the following
standards:
(1) Except during a civil emergency or
any unanticipated grave natural disaster
or other natural phenomenon of an
exceptional, inevitable and irresistible
character, the effects of which could not
have been prevented or avoided by the
exercise of due care or foresight, each
stationary pesticide container (for liquid
and dry pesticides) and its
appurtenances must meet both of the
following standards:
(i) Each stationary pesticide container
and its appurtenances must be resistant
to extreme changes in temperature and
constructed of materials that are
adequately thick to not fail and that are
resistant to corrosion, puncture, or
cracking.
(ii) Each stationary pesticide
container must be capable of
withstanding all operating stresses,
taking into account static heat, pressure
buildup from pumps and compressors,
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and any other foreseeable mechanical
stresses to which the container may be
subjected in the course of operations.
(2) Each stationary liquid pesticide
container must meet all of the following
standards:
(i) Each stationary liquid pesticide
container must be equipped with a vent
or other device designed to relieve
excess pressure, prevent losses by
evaporation, and exclude precipitation.
(ii) External sight gauges, which are
pesticide-containing hoses or tubes that
run vertically along the exterior of the
container from the top to the bottom, are
prohibited on stationary liquid pesticide
containers.
(iii) Each stationary liquid pesticide
container connection below the normal
liquid level must be equipped with a
shutoff valve which is capable of being
locked closed. A shutoff valve must be
located within a secondary containment
unit if one is required by subpart E of
this part.
(g) Can I obtain a waiver from or a
modification to any of the refillable
container standards? Yes, it is possible
for you to obtain a waiver from or a
modification to some of the refillable
container standards, as follows:
(1) EPA may waive or modify the
requirements of paragraph (a) of this
section regarding the DOT standards for
pesticide products that are not DOT
hazardous materials if EPA determines
that an alternative (partial or modified)
set of standards or pre-existing
requirements achieves a level of safety
that is at least equal to that specified in
the requirements of paragraph (a) of this
section.
(2) EPA may waive or modify the
requirements of paragraph (b) of this
section regarding the DOT standards for
pesticide products that are DOT
hazardous materials if EPA determines
that an alternative (partial or modified)
set of standards or pre-existing
requirements achieves a level of safety
that is at least equal to that specified in
the requirements of paragraph (b) of this
section. EPA will modify or waive the
requirements of paragraph (b) of this
section only after consulting with DOT
to ensure consistency with DOT
regulations and exemptions.
(h) How do I obtain a waiver from or
a modification to any of the refillable
container standards? To obtain a waiver
from or a modification to any of the
refillable container standards, you must
submit a written request for a waiver or
a modification to the EPA to the
following address: Office of Pesticide
Programs (7504P); U.S. Environmental
Protection Agency; Ariel Rios Building;
1200 Pennsylvania Avenue, N.W.,
Washington, DC 20460. You cannot
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distribute or sell the pesticide product
in a refillable container that does not
comply with all of the refillable
container standards unless and until
EPA approves the request for the waiver
or modification in writing. You must
include two copies of the following
information (which may be part of an
application for registration or amended
registration) with your written request:
(1) The name and address of the
registrant; the date; and the name, title,
signature, and phone number of the
company official making the request.
(2) The name and EPA registration
number of the pesticide product for
which the waiver or modification is
requested.
(3) A statement specifying the
requirement or requirements from
which you are requesting a waiver or a
modification.
(4) A description of the refillable
container or containers for which the
waiver or modification is requested.
(5) Documentation or justification to
demonstrate that the applicable waiver
or modification criteria in paragraph (g)
of this section are satisfied.
§ 165.47 What information must I report
about my refillable containers?
You are not required to report to EPA
with information about your refillable
containers under the regulations in this
subpart. You should refer to the
reporting standards in part 159 of this
chapter to determine if information on
container failures or other incidents
involving pesticide containers must be
reported to EPA under FIFRA section
6(a)(2) (7 U.S.C. 136d(a)(2)).
§§ 165.48–165.59
[Reserved]
Subpart D—Standards for
Repackaging Pesticide Products into
Refillable Containers
§ 165.60
General provisions.
(a) What is the purpose of the
regulations in this subpart? The
regulations in this subpart establish
requirements for repackaging some
pesticide products into refillable
containers for distribution or sale.
(b) Do I have to comply with the
regulations in this subpart? You must
comply with the regulations in this
subpart if you are a registrant who
distributes or sells a pesticide product
in refillable containers, if you are a
registrant who distributes or sells
pesticide products to a refiller (that is
not part of your company) for
repackaging into refillable containers, or
if you are a refiller of a pesticide
product and you are not the registrant
of the pesticide product. Each pesticide
product that is subject to the regulations
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in this subpart as set out in § 165.63 and
that is distributed or sold in a refillable
container must be distributed or sold in
compliance with the standards of these
regulations.
(c) When do I have to comply? As of
August 16, 2011, all pesticide products
distributed or sold by you in refillable
containers must be distributed or sold in
compliance with these regulations.
§ 165.63 Scope of pesticide products
included.
(a) Are manufacturing use products
subject to the regulations in this
subpart? No, the regulations in this
subpart do not apply to manufacturing
use products, as defined in § 158.153(h)
of this chapter.
(b) Are plant-incorporated protectants
subject to the regulations in this
subpart? No, the regulations in this
subpart do not apply to plantincorporated protectants, as defined in
§ 174.3 of this chapter.
(c) Which antimicrobial pesticide
products are not subject to the
regulations in this subpart? The
regulations in this subpart do not apply
to a pesticide product if it satisfies all
of the following conditions:
(1) The pesticide product meets one of
the following two criteria:
(i) The pesticide product is an
antimicrobial pesticide as defined in
FIFRA section 2(mm); or
(ii) The pesticide product: (A) Is
intended to: disinfect, sanitize, reduce
or mitigate growth or development of
microbiological organisms; or protect
inanimate objects, industrial processes
or systems, surfaces, water, or other
chemical substances from
contamination, fouling, or deterioration
caused by bacteria, viruses, fungi,
protozoa, algae, or slime; and
(B) In the intended use is subject to
a tolerance under section 408 of the
Federal Food, Drug, and Cosmetic Act
or a food additive regulation under
section 409 of such Act.
(2) The labeling of the pesticide
product includes directions for use on a
site in at least one of the following
antimicrobial product use categories:
food handling/storage establishments
premises and equipment; commercial,
institutional, and industrial premises
and equipment; residential and public
access premises; medical premises and
equipment; human drinking water
systems; materials preservatives;
industrial processes and water systems;
antifouling coatings; wood
preservatives; or swimming pools.
(3) The pesticide product is not a
hazardous waste as set out in part 261
of this chapter when the pesticide
product is intended to be disposed.
(4) EPA has not specifically
determined that the pesticide product
must be subject to the regulations in this
subpart to prevent an unreasonable
adverse effect on the environment
according to the provisions of paragraph
(e) of this section.
(d) Which requirements must an
antimicrobial swimming pool product
comply with if it is not exempt from
these regulations? (1) An antimicrobial
swimming pool product that is not
exempt by paragraph (a), (b), or (c) of
this section must comply with all of the
regulations in this subpart except for the
following requirements:
Requirement for
registrants who
distribute or sell
directly in refillable
containers
Requirement
Recordkeeping specific to each instance of repackaging
Requirement for
refillers who are
not registrants
§ 165.65(i)(2)
§ 165.70(j)(2)
Container inspection: criteria regarding a serial number or other identifying code
§ 165.65(e)(3)
§ 165.70(f)(3)
Container inspection: criteria regarding one-way valve or tamper-evident device
§ 165.65(e)(4)
§ 165.70(f)(4)
Cleaning requirement: criteria regarding one-way valve or tamper-evident device
§ 165.65(f)(1)
§ 165.70(g)(1)
§ 165.65(g)
§ 165.70(h)
Cleaning if the one-way valve or tamper-evident device is not intact
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(2) For the purposes of this subpart,
an antimicrobial swimming pool
product is a pesticide product that
satisfies both of the following
conditions:
(i) The pesticide product is intended
to: disinfect, sanitize, reduce or mitigate
growth or development of
microbiological organisms; or protect
inanimate objects, industrial processes
or systems, surfaces, water, or other
chemical substances from
contamination, fouling, or deterioration
caused by bacteria, viruses, fungi,
protozoa, algae, or slime.
(ii) The labeling of the pesticide
product includes directions for use on
only a site or sites in the antimicrobial
product use category of swimming
pools.
(e) How will EPA determine if an
antimicrobial pesticide product
otherwise exempted must be subject to
the regulations in this subpart to
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prevent an unreasonable adverse effect
on the environment? (1) EPA may
determine that an antimicrobial
pesticide product otherwise exempted
by paragraph (c) of this section must be
subject to the repackaging regulations in
this subpart to prevent an unreasonable
adverse effect on the environment if all
of the following conditions exist:
(i) EPA obtains information, data or
other evidence of a problem with the
containers of a certain pesticide product
or related group of products.
(ii) The information, data or other
evidence is reliable and factual.
(iii) The problem causes or could
reasonably be expected to cause an
unreasonable adverse effect on the
environment.
(iv) Complying with the container
regulations could reasonably be
expected to eliminate the problem.
(2) If EPA determines that an
antimicrobial pesticide product
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otherwise exempted by paragraph (c) of
this section must be subject to the
repackaging regulations in this subpart
to prevent an unreasonable adverse
effect on the environment, EPA may
require, by rule, that the product be
repackaged in compliance with all or
some of the requirements in this
subpart. Alternatively, EPA may notify
the applicant or registrant of its intent
to make such a determination. After
allowing the applicant or registrant a
reasonable amount of time to reply, EPA
may require, by notification and as a
condition of registration, that the
product be repackaged in compliance
with all or some of the requirements in
this subpart. For the purpose of the
previous sentence, 60 days would be a
reasonable amount of time to reply,
although EPA may, in its discretion,
provide more time. EPA may deny
registration or initiate cancellation
proceedings if the registrant fails to
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comply with the repackaging
regulations within the time frames
established by EPA in the rule or in its
notification.
(f) What other pesticide products are
subject to the regulations in this
subpart? The regulations in this subpart
apply to all pesticide products other
than manufacturing use products, plantincorporated protectants, and
antimicrobial products that are exempt
paragraph (c) of this section.
Antimicrobial products covered under
paragraph (d) of this section are subject
to the regulations indicated in that
section.
(g) What does ‘‘pesticide product’’ or
‘‘pesticide’’ mean in the rest of this
subpart? In §§ 165.63(h) through 165.70,
the term ‘‘pesticide product’’ or
‘‘pesticide’’ refers only to a pesticide
product or a pesticide that is subject to
the regulations in this subpart as
described in paragraphs (a) through (f)
of this section.
(h) Are there any other exceptions? (1)
The regulations in this subpart do not
apply to transport vehicles that contain
pesticide in pesticide-holding tanks that
are an integral part of the transport
vehicle and that are the primary
containment for the pesticide.
(2) Custom blending is not subject to
the regulations in this subpart.
(3) The regulations in this subpart do
not apply to containers that hold
pesticides that are gaseous at
atmospheric temperature and pressure.
jlentini on PROD1PC65 with RULES2
§ 165.65 Registrants who distribute or sell
pesticide products in refillable containers.
(a) Must I comply with the standards
in this section? You must comply with
the standards in this section if you are
a registrant who distributes or sells
pesticide products in refillable
containers. This means that you conduct
all of the repackaging for a pesticide
product and that you do not distribute
or sell the pesticide product to a refiller
that is not part of your company for
repackaging into refillable containers. If
you are a registrant that repackages a
product directly into refillable
containers for sale or distribution and
you also sell or distribute other
quantities of that product to an
independent refiller for repackaging,
then you must meet the requirements in
this section for those quantities you
distribute or sell directly and the
requirements in § 165.67 for those
quantities that you distribute or sell to
an independent refiller.
(b) Am I responsible for product
integrity? Yes, you are responsible for
the pesticide product that you distribute
or sell in refillable containers not being
adulterated or different from the
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composition described in its
confidential statement of formula that is
required under FIFRA section 3.
(c) What information must I develop?
For each pesticide product distributed
or sold in refillable containers, you must
develop both of the following
documents in writing.
(1) You must develop a refilling
residue removal procedure that
describes how to remove pesticide
residue from a refillable container
(portable or stationary pesticide
container) before it is refilled.
(i) The refilling residue removal
procedure must be adequate to ensure
that the composition of the pesticide
product does not differ at the time of its
distribution or sale from the
composition described in its
confidential statement of formula that is
required under FIFRA section 3.
(ii) If the refilling residue removal
procedure requires the use of a solvent
other than the diluent used for applying
the pesticide as specified on the labeling
under ‘‘Directions for Use,’’ or if there
is no diluent used for application, the
refilling residue removal procedure
must describe how to manage any
rinsate resulting from the procedure in
accordance with applicable Federal and
State regulations.
(2) You must develop a description of
acceptable refillable containers (portable
or stationary pesticide containers) that
can be used for distributing or selling
that pesticide product.
(i) An acceptable container is one that
you have determined meets the
standards in subpart C of this part and
is compatible with the pesticide
formulation intended to be distributed
and sold using the refillable container.
(ii) You must identify the containers
by specifying the container materials of
construction that are compatible with
the pesticide formulation and specifying
information necessary to confirm
compliance with the refillable container
requirements in subpart C of this part.
(d) What requirements must my
individual establishments follow
regarding repackaging a pesticide
product into refillable containers? A
refiller at your individual establishment
that repackages a pesticide product into
refillable containers for distribution or
sale must comply with all of the
following provisions.
(1) The establishment must be
registered with EPA as a producing
establishment as required by § 167.20 of
this chapter.
(2) The refiller must not change the
pesticide formulation unless the refiller
has a registration for the new
formulation.
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(3) The refiller must repackage a
pesticide product only into a refillable
container that is identified on your
description of acceptable containers for
that pesticide product.
(4) The refiller may repackage any
quantity of a pesticide product into a
refillable container up to the rated
capacity of the container. In addition,
there are no general limits on the size
of the refillable containers that the
refiller can use.
(5) The refiller must have all of the
following items at the establishment
before repackaging a pesticide product
into any refillable container for
distribution or sale:
(i) The pesticide product’s label and
labeling.
(ii) The written refilling residue
removal procedure for the pesticide
product.
(iii) The written description of
acceptable containers for the pesticide
product.
(6) Before repackaging a pesticide
product into any refillable container for
distribution or sale, the refiller must
identify the pesticide product
previously contained in the refillable
container to determine whether a
residue removal procedure must be
conducted in accordance with
paragraph (f) of this section. The refiller
may identify the previous pesticide
product by referring to the label or
labeling.
(7) The refiller must inspect each
refillable container according to
paragraph (e) of this section.
(8) The refiller must clean each
refillable container according to
paragraph (f) or (g) of this section, if
required by either paragraph.
(9) The refiller must ensure that each
refillable container is properly labeled
according to paragraph (h) of this
section.
(10) The establishment must maintain
records in accordance with paragraph (i)
of this section.
(11) The establishment must maintain
records as required by part 169 of this
chapter.
(12) The establishment must report as
required by part 167 of this chapter.
(e) How must my individual
establishments inspect refillable
containers? Before repackaging a
pesticide product into any refillable
container, a refiller at your
establishment must visually inspect the
exterior and (if possible) the interior of
the container and the exterior of
appurtenances. The purpose of the
inspection is to determine whether the
container meets the necessary criteria
with respect to continued container
integrity, required markings, and
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openings. If the condition in paragraph
(e)(1) of this section exists, the container
fails the inspection and must not be
refilled unless the container is repaired,
reconditioned, or remanufactured in
compliance with the relevant DOT
requirement. If the condition in
paragraph (e)(2) or (e)(3) of this section
exists (or both), the container fails the
inspection and must not be refilled until
the container meets the standards
specified in subpart C of this part. The
conditions are:
(1) The integrity of the container is
compromised in at least one of the
following ways:
(i) The container shows signs of
rupture or other damage which reduces
its structural integrity.
(ii) The container has visible pitting,
significant reduction in material
thickness, metal fatigue, damaged
threads or closures, or other significant
defects.
(iii) The container has cracks,
warpage, corrosion or any other damage
which might render it unsafe for
transportation.
(iv) There is damage to the fittings,
valves, tamper-evident devices or other
appurtenances that may cause failure of
the container.
(2) The container does not bear the
markings required by § 165.45(a), (b)
and (d), or such markings are not
legible.
(3) The container does not have an
intact and functioning one-way valve or
tamper-evident device on each opening
other than a vent, if required.
(f) How must my individual
establishments clean refillable
containers? A refiller at your
establishment must clean each refillable
container by conducting the pesticide
product’s refilling residue removal
procedure before repackaging the
pesticide product into the refillable
container, unless the conditions in
paragraph (f)(1) of this section and
either paragraph (f)(2) or (f)(3) of this
section are satisfied:
(1) If required, each tamper-evident
device and one-way valve is intact.
(2) The refillable container is being
refilled with the same pesticide product.
(3) Both of the following conditions
are satisfied:
(i) The container previously held a
pesticide product with a single active
ingredient and is being used to
repackage a pesticide product with the
same single active ingredient.
(ii) There is no change that would
cause the composition of the product
being repackaged to differ from the
composition described in its
confidential statement of formula that is
required under FIFRA section 3.
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Examples of unallowable changes
include the active ingredient
concentration increasing or decreasing
beyond the limits established by the
confidential statement of formula or a
reaction or interaction between the
pesticide product being repackaged and
the residue remaining in the container.
(g) How must my individual
establishments clean a refillable
container that has a broken (non-intact)
tamper-evident device or one-way valve?
As required in paragraph (f) of this
section, a refiller at your establishment
must clean each refillable container that
has a tamper-evident device or one-way
valve that is not intact by conducting
the pesticide product’s refilling residue
removal procedure before repackaging
the pesticide product into the refillable
container. In addition, other procedures
may be necessary to assure that product
integrity is maintained in such cases.
(h) How must my individual
establishments label refillable
containers? Before distributing or
selling a pesticide product in a refillable
container, a refiller at your
establishment must ensure that the label
of the pesticide product is securely
attached to the refillable container such
that the label can reasonably be
expected to remain affixed during the
foreseeable conditions and period of
use. The label and labeling must comply
in all respects with the requirements of
part 156 of this chapter. In particular,
the refiller at your establishment must
ensure that the net contents statement
and EPA establishment number appear
on the label.
(i) What recordkeeping must my
individual establishments do? Each of
your individual establishments that
repackages a pesticide product into
refillable containers for distribution or
sale must maintain all of the records
listed in this section in addition to the
applicable records identified in parts
167 and 169 of this chapter. The
establishment must furnish these
records for inspection and copying upon
request by an employee of EPA or any
entity designated by EPA, such as a
State, another political subdivision or a
Tribe.
(1) For each pesticide product
distributed or sold in refillable
containers, both of the following records
must be maintained for the current
operating year and for 3 years after that:
(i) The written refilling residue
removal procedure for the pesticide
product.
(ii) The written description of
acceptable containers for the pesticide
product.
(2) Each time a refiller at your
establishment repackages a pesticide
PO 00000
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47431
product into a refillable container and
distributes or sells the product, the
following records must be generated and
maintained for at least 3 years after the
date of repackaging:
(i) The EPA registration number of the
pesticide product distributed or sold in
the refillable container.
(ii) The date of the repackaging.
(iii) The serial number of the refillable
container.
§ 165.67 Registrants who distribute or sell
pesticide products to refillers for
repackaging.
(a) Must I comply with the standards
in this section? You must comply with
the standards in this section if you are
a registrant who distributes or sells
pesticide products to a refiller that is
not part of your company for
repackaging into refillable containers.
(b) Under what conditions can I allow
a refiller to repackage my pesticide
product into refillable containers? You
may allow a refiller to repackage your
pesticide product into refillable
containers and to distribute or sell such
repackaged product under your existing
registration if all of the following
conditions are satisfied:
(1) The repackaging results in no
change to the pesticide formulation.
(2) One of the following conditions
regarding a registered refilling
establishment is satisfied:
(i) The pesticide product is
repackaged at a refilling establishment
registered with EPA as required by
§ 167.20 of this chapter.
(ii) The pesticide product is
repackaged at the site of a user who
intends to use or apply the product by
a refilling establishment registered with
EPA as required by § 167.20 of this
chapter.
(3) You have entered into a written
contract with the refiller to repackage
the pesticide product and to use the
label of your pesticide product.
(4) The pesticide product is
repackaged only into refillable
containers that meet the standards of
subpart C of this part.
(5) The pesticide product is labeled
with the product’s label with no
changes except the addition of an
appropriate net contents statement and
the refiller’s EPA establishment number.
(c) What violations are applicable to
illegal repackaging? Repackaging a
pesticide product for distribution or sale
without either obtaining a registration or
meeting all of the conditions in
paragraph (b) of this section is a
violation of section 12 of the Act. Both
you and the refiller that is repackaging
your pesticide product under written
contract with you may be liable for
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violations pertaining to the repackaged
product.
(d) When must I provide the written
contract to the refiller? If you allow a
refiller to repackage your product as
specified in paragraph (b) of this section
you must provide the written contract to
the refiller before you distribute or sell
the pesticide product to the refiller.
(e) Am I responsible for product
integrity? Yes, for a product that you
distribute or sell to a refiller that is not
part of your company for repackaging
into refillable containers, you are
responsible for the pesticide product not
being adulterated or different from the
composition described in its
confidential statement of formula that is
required under FIFRA section 3.
(f) What information must I develop?
For each pesticide product distributed
or sold in refillable containers, you must
develop both of the following
documents in writing.
(1) You must develop a refilling
residue removal procedure that
describes how to remove pesticide
residue from a refillable container
(portable or stationary pesticide
container) before it is refilled.
(i) The refilling residue removal
procedure must be adequate to ensure
that the composition of the pesticide
product does not differ at the time of its
distribution or sale from the
composition described in its
confidential statement of formula that is
required under FIFRA section 3.
(ii) If the refilling residue removal
procedure requires the use of a solvent
other than the diluent used for applying
the pesticide as specified on the labeling
under ‘‘Directions for Use,’’ or if there
is no diluent used for application, the
refilling residue removal procedure
must describe how to manage any
rinsate resulting from the procedure in
accordance with applicable Federal and
State regulations.
(2) You must develop a description of
acceptable refillable containers (portable
or stationary pesticide containers) that
can be used for distributing or selling
that pesticide product.
(i) An acceptable container is one that
you have determined meets the
standards in subpart C of this part and
is compatible with the pesticide
formulation intended to be distributed
and sold using the refillable container.
(ii) You must identify the containers
by specifying the container materials of
construction that are compatible with
the pesticide formulation and specifying
information necessary to confirm
compliance with the refillable container
requirements in subpart C of this part.
(g) When must I provide the
information to the refiller? You must
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Jkt 208001
provide the refiller with all of the
following information and
documentation before or at the time of
distribution or sale of your pesticide
product to the refiller:
(1) Your written refilling residue
removal procedure for the pesticide
product.
(2) Your written description of
acceptable containers for the pesticide
product.
(3) The pesticide product’s label and
labeling.
(h) What recordkeeping must I do?
You must maintain all of the records
listed in this section for the current
operating year and for 3 years after that.
You must furnish these records for
inspection and copying upon request by
an employee of EPA or any entity
designated by EPA, such as a State,
another political subdivision or a Tribe:
(1) Each written contract entered into
with a refiller for repackaging your
pesticide product into refillable
containers.
(2) Your written refilling residue
removal procedure for the pesticide
product.
(3) Your written description of
acceptable containers for the pesticide
product.
§ 165.70
Refillers who are not registrants.
(a) Must I comply with the standards
in this section? You must comply with
the standards in this section if you are
a refiller of a pesticide product and you
are not the registrant of the pesticide
product.
(b) Under what conditions can I
repackage a registrant’s pesticide
product into refillable containers? A
registrant may allow you to repackage
the registrant’s pesticide product into
refillable containers and to distribute or
sell such repackaged product under the
registrant’s existing registration if all of
the following conditions are satisfied:
(1) The repackaging results in no
change to the pesticide formulation.
(2) One of the following conditions
regarding a registered refilling
establishment is satisfied:
(i) The pesticide product is
repackaged at a refilling establishment
registered with EPA as required by
§ 167.20 of this chapter.
(ii) The pesticide product is
repackaged at the site of a user who
intends to use or apply the product by
a refilling establishment registered with
EPA as required by § 167.20 of this
chapter.
(3) The registrant has entered into a
written contract with you to repackage
the pesticide product and to use the
label of the registrant’s pesticide
product.
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(4) The pesticide product is
repackaged only into refillable
containers that meet the standards of
subpart C of this part.
(5) The pesticide product is labeled
with the product’s label with no
changes except the addition of an
appropriate net contents statement and
the refillers EPA establishment number.
(c) What violations are applicable to
illegal repackaging? Repackaging a
pesticide product for distribution or sale
without either obtaining a registration or
meeting all of the conditions in
paragraph (b) of this section is a
violation of section 12 of the Act. Both
you and the pesticide product’s
registrant may be liable for violations
pertaining to the repackaged product.
(d) Am I responsible for product
integrity? Yes, you are responsible for
the pesticide product that you distribute
or sell in refillable containers not being
adulterated or different from the
composition described in its
confidential statement of formula that is
required under FIFRA section 3.
(e) What requirements must I follow
regarding repackaging a pesticide
product into refillable containers? You
must comply with all of the following
provisions.
(1) Your establishment must be
registered with EPA as a producing
establishment as required by § 167.20 of
this chapter.
(2) You must not change the pesticide
formulation unless you have a
registration for the new formulation.
(3) You must repackage a pesticide
product only into a refillable container
that is identified on the description of
acceptable containers for that pesticide
product provided by the registrant.
(4) You may repackage any quantity of
a pesticide product into a refillable
container up to the rated capacity of the
container. In addition, there are no
general limits on the size of the
refillable containers that you can use.
(5) You must have all of the following
items at your establishment before
repackaging a pesticide product into any
refillable container for distribution or
sale:
(i) The written contract from the
pesticide product’s registrant.
(ii) The pesticide product’s label and
labeling.
(iii) The registrant’s written refilling
residue removal procedure for the
pesticide product.
(iv) The registrant’s written
description of acceptable containers for
the pesticide product.
(6) Before repackaging a pesticide
product into any refillable container for
distribution or sale, you must identify
the pesticide product previously
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contained in the refillable container to
determine whether a residue removal
procedure must be conducted in
accordance with paragraph (g) of this
section. You may identify the previous
pesticide product by referring to the
label or labeling.
(7) You must inspect each refillable
container according to paragraph (f) of
this section.
(8) You must clean each refillable
container according to paragraph (g) or
(h) of this section, if required by either
paragraph.
(9) You must ensure that each
refillable container is properly labeled
according to paragraph (i) of this
section.
(10) You must maintain records in
accordance with paragraph (j) of this
section.
(11) You must maintain records as
required by part 169 of this chapter.
(12) You must report as required by
part 167 of this chapter.
(13) The stationary pesticide
containers at your establishment must
meet the standards in § 165.45(f).
(14) You may be required to comply
with the containment standards in
subpart E of this part.
(f) How must I inspect refillable
containers? Before repackaging a
pesticide product into any refillable
container, you must visually inspect the
exterior and (if possible) the interior of
the container and the exterior of
appurtenances. The purpose of the
inspection is to determine whether the
container meets the necessary criteria
with respect to continued container
integrity, required markings, and
openings. If the condition in paragraph
(f)(1) of this section exists, the container
fails the inspection and must not be
refilled unless the container is repaired,
reconditioned, or remanufactured in
compliance with the relevant DOT
requirement. If the condition in
paragraph (f)(2) or (f)(3) of this section
exists (or both), the container fails the
inspection and must not be refilled until
the container meets the standards
specified in subpart C of this part. The
conditions are:
(1) The integrity of the container is
compromised in at least one of the
following ways:
(i) The container shows signs of
rupture or other damage which reduces
its structural integrity.
(ii) The container has visible pitting,
significant reduction in material
thickness, metal fatigue, damaged
threads or closures, or other significant
defects.
(iii) The container has cracks,
warpage, corrosion or any other damage
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which might render it unsafe for
transportation.
(iv) There is damage to the fittings,
valves, tamper-evident devices or other
appurtenances that may cause failure of
the container.
(2) The container does not bear the
markings required by § 165.45(a), (b)
and (d), or such markings are not
legible.
(3) The container does not have an
intact and functioning one-way valve or
tamper-evident device on each opening
other than a vent, if required.
(g) How must I clean refillable
containers? You must clean each
refillable container by conducting the
pesticide product’s refilling residue
removal procedure before repackaging
the pesticide product into the refillable
container, unless the conditions in
paragraph (g)(1) of this section and
either paragraph (g)(2) or (g)(3) of this
section are satisfied:
(1) If required, each tamper-evident
device and one-way valve is intact.
(2) The refillable container is being
refilled with the same pesticide product.
(3) Both of the following conditions
are satisfied.
(i) The container previously held a
pesticide product with a single active
ingredient and is being used to
repackage a pesticide product with the
same single active ingredient.
(ii) There is no change that would
cause the composition of the product
being repackaged to differ from the
composition described in its
confidential statement of formula that is
required under FIFRA section 3.
Examples of unallowable changes
include the active ingredient
concentration increasing or decreasing
beyond the limits established by the
confidential statement of formula or a
reaction or interaction between the
pesticide product being repackaged and
the residue remaining in the container.
(h) How must I clean a refillable
container that has a broken (non-intact)
tamper-evident device or one-way valve?
As required in paragraph (g) of this
section, you must clean each refillable
container that has a tamper-evident
device or one-way valve that is not
intact by conducting the pesticide
product’s refilling residue removal
procedure before repackaging the
pesticide product into the refillable
container. In addition, other procedures
may be necessary to assure that product
integrity is maintained in such cases.
(i) How must I label refillable
containers? Before distributing or
selling a pesticide product in a refillable
container, you must ensure that the
label of the pesticide product is securely
attached to the refillable container such
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that the label can reasonably be
expected to remain affixed during the
foreseeable conditions and period of
use. The label and labeling must comply
in all respects with the requirements of
part 156 of this chapter. In particular,
you must ensure that the net contents
statement and EPA establishment
number appear on the label.
(j) What recordkeeping must I do? You
must maintain all of the records listed
in this section in addition to the
applicable records identified in parts
167 and 169 of this chapter. You must
furnish these records for inspection and
copying upon request by an employee of
EPA or any entity designated by EPA,
such as a State, another political
subdivision or a Tribe.
(1) For each pesticide product
distributed or sold in refillable
containers, all of the following records
must be maintained for the current
operating year and for 3 years after that:
(i) The written contract from the
pesticide product’s registrant for the
pesticide product.
(ii) The written refilling residue
removal procedure for the pesticide
product.
(iii) The written description of
acceptable containers for the pesticide
product.
(2) Each time you repackage a
pesticide product into a refillable
container and distribute or sell the
product, the following records must be
generated and maintained for at least 3
years after the date of repackaging:
(i) The EPA registration number of the
pesticide product distributed or sold in
the refillable container.
(ii) The date of the repackaging.
(iii) The serial number of the refillable
container.
§§ 165.71–165.79
[Reserved]
Subpart E—Standards for Pesticide
Containment Structures
§ 165.80
General provisions.
(a) What is the purpose of the
regulations in this subpart? The purpose
of the containment regulations in this
subpart is to protect human health and
the environment from exposure to
agricultural pesticides which may spill
or leak from stationary pesticide
containers. This protection is achieved
by the construction of secondary
containment units or pads at certain
facilities handling agricultural
pesticides. These regulations will also
reduce waste generation associated
with:
(1) Storage and handling of large
quantities of pesticide products.
(2) Pesticide dispensing and
container-refilling operations.
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(b) Do I have to comply with the
regulations in this subpart? You must
comply with the regulations in this
subpart if you are an owner or operator
of one of the following businesses and
if you also have a stationary pesticide
container or a pesticide dispensing
(including container refilling) area:
(1) Refilling establishments who
repackage agricultural pesticides and
whose principal business is retail sale
(i.e., more that 50% of total annual
revenue comes from retail operations).
(2) Custom blenders of agricultural
pesticides.
(3) Businesses which apply an
agricultural pesticide for compensation
(other than trading of personal services
between agricultural producers).
(c) When do I have to comply? You
must comply with all applicable
containment regulations for new and
existing structures as of August 17,
2009.
jlentini on PROD1PC65 with RULES2
§ 165.81 Scope of stationary pesticide
containers included.
(a) What is a stationary pesticide
container? A stationary pesticide
container is a refillable container that is
fixed at a single facility or
establishment, or, if not fixed, remains
at the facility or establishment for at
least 30 consecutive days, and that
holds pesticide during the entire time.
(b) What stationary pesticide
containers are subject to the regulations
in this subpart? Stationary pesticide
containers designed to hold undivided
quantities of agricultural pesticides
equal to or greater than 500 gallons
(1,890 liters) of liquid pesticide or equal
to or greater than 4,000 pounds (1,818
kilograms) of dry pesticide are subject to
the regulations in this subpart and must
have a secondary containment unit that
complies with the provisions of this
subpart unless any of the following
conditions exists:
(1) The container is empty, that is, all
pesticide that can be removed by
methods such as draining, pumping or
aspirating has been removed (whether
or not the container has been rinsed or
washed).
(2) The container holds only pesticide
rinsates or wash waters, and is labeled
accordingly.
(3) The container holds only
pesticides which would be gaseous
when released at atmospheric
temperature and pressure.
(4) The container is dedicated to nonpesticide use, and is labeled
accordingly.
§ 165.82 Scope of pesticide dispensing
areas included.
(a) What pesticide dispensing areas
are subject to the regulations in this
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subpart? A pesticide dispensing area is
subject to the containment regulations
in this subpart and must have a
containment pad that complies with the
requirements of this subpart if any of
the following activities occur:
(1) Refillable containers of
agricultural pesticide are emptied,
cleaned or rinsed.
(2) Agricultural pesticides are
dispensed from a stationary pesticide
container designed to hold undivided
quantities of agricultural pesticides
equal to or greater than 500 gallons
(1,890 liters) of liquid pesticide or equal
to or greater than 4,000 pounds (1,818
kilograms) of dry pesticide for any
purpose, including refilling or emptying
for cleaning. This applies when
pesticide is dispensed from the
container into any vessel, including, but
not limited to:
(i) Refillable containers;
(ii) Service containers;
(iii) Transport vehicles;
(iv) Application equipment.
(3) Agricultural pesticides are
dispensed from a transport vehicle for
purposes of filling a refillable container.
(4) Agricultural pesticides are
dispensed from any other container for
the purpose of refilling a refillable
container for sale or distribution.
Containment requirements do not apply
if the agricultural pesticide is dispensed
from such a container for use,
application or purposes other than
refilling for sale or distribution.
(b) What pesticide dispensing areas
are exempt from the regulations in this
subpart? A pesticide dispensing area is
exempt from the regulations in this
subpart if any of the following
conditions exist:
(1) The only pesticides in the
dispensing area would be gaseous when
released at atmospheric temperature and
pressure.
(2) The only pesticide containers
refilled or emptied within the
dispensing area are stationary pesticide
containers which are already protected
by a secondary containment unit that
complies with the provisions of this
subpart.
(3) The pesticide dispensing area is
used solely for dispensing pesticide
from a rail car which does not remain
at a facility long enough to meet the
definition of a stationary pesticide
container; that is, 30 days.
§ 165.83 Definition of new and existing
structures.
(a) What is a new containment
structure? A new containment structure
is one whose installation began after
November 16, 2006. Installation is
considered to have begun if:
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(1) You, as the owner or operator,
have obtained all Federal, State, and
local approvals or permits necessary to
begin physical construction of the
containment structure; AND
(2) You have either begun a
continuous on-site physical
construction or installation program OR
you have entered into contractual
obligations. The contract must be such
that it cannot be canceled or modified
without substantial loss, and must be for
the physical construction or installation
of the containment structure within a
specific and reasonable time frame.
(b) What is an existing containment
structure? An existing containment
structure is defined as one whose
installation began on or before
November 16, 2006.
§ 165.85 Design and capacity
requirements for new structures.
(a) For all new containment
structures, what construction materials
must I use? These are the material
specifications for a new containment
structure:
(1) The containment structure must be
constructed of steel, reinforced concrete
or other rigid material capable of
withstanding the full hydrostatic head,
load and impact of any pesticides,
precipitation, other substances,
equipment and appurtenances placed
within the structure. The structure must
be liquid-tight with cracks, seams and
joints appropriately sealed.
(2) The structure must not be
constructed of natural earthen material,
unfired clay, or asphalt.
(3) The containment structure must be
made of materials compatible with the
pesticides stored. In this case,
compatible means able to withstand
anticipated exposure to stored or
transferred materials and still provide
secondary containment of those same or
other materials within the containment
area.
(b) For all new containment
structures, what are the general design
requirements? These are the general
design requirements for new
containment structures:
(1) You must protect appurtenances
and pesticide containers against damage
from operating personnel and moving
equipment. Means of protection
include, but are not limited to, supports
to prevent sagging, flexible connections,
the use of guard rails, barriers, and
protective cages.
(2) Appurtenances, discharge outlets
or gravity drains must not be configured
through the base or wall of the
containment structure, except for direct
interconnections between adjacent
containment structures which meet the
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requirements of this subpart.
Appurtenances must be configured in
such a way that spills or leaks are easy
to see.
(3) The containment structure must be
constructed with sufficient freeboard to
contain precipitation and prevent water
and other liquids from seeping into or
flowing onto it from adjacent land or
structures.
(4) Multiple stationary pesticide
containers may be protected within a
single secondary containment unit.
(c) For new stationary liquid pesticide
containment and new containment pads
in pesticide dispensing areas, what are
the capacity requirements? These are
the capacity requirements:
(1) New secondary containment units
for stationary liquid pesticide
containers, if protected from
precipitation, must have a capacity of at
least 100 percent of the volume of the
largest stationary pesticide container
plus the volume displaced by other
containers and appurtenances within
the unit.
(2) New secondary containment units
for stationary liquid pesticide
containers, if exposed to or unprotected
from precipitation, must have a capacity
of at least 110 percent of the volume of
the largest stationary pesticide container
plus the volume displaced by other
containers and appurtenances within
the unit.
(3) New containment pads in
pesticide dispensing areas which have a
pesticide container or pesticide-holding
equipment with a volume of 750 gallons
or greater must have a holding capacity
of at least 750 gallons.
(4) New containment pads in
pesticide dispensing areas which do not
have a pesticide container or pesticideholding equipment with a volume of at
least 750 gallons must have a holding
capacity of at least 100 percent of the
volume of the largest pesticide container
or pesticide-holding equipment used on
the pad.
(d) For new stationary liquid pesticide
containment, what are the specific
design requirements? You must either
anchor or elevate each new stationary
liquid pesticide container protected by
a secondary containment unit to prevent
flotation in the event that the secondary
containment unit fills with liquid.
(e) For new containment pads in
pesticide dispensing areas, what are the
specific design requirements? Each new
containment pad in a pesticide
dispensing area must:
(1) Be designed and constructed to
intercept leaks and spills of pesticides
which may occur in the pesticide
dispensing area.
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(2) Have enough surface area to
extend completely beneath any
container on it, with the exception of
transport vehicles dispensing pesticide
for sale or distribution to a stationary
pesticide container. For such vehicles,
the surface area of the containment pad
must accommodate at least the portion
of the vehicle where the delivery hose
or device couples to the vehicle. This
exception does not apply to transport
vehicles that are used for prolonged
storage or repeated on-site dispensing of
pesticides.
(3) Allow, in conjunction with its
sump, for removal and recovery of
spilled, leaked, or discharged material
and rainfall, such as by a manually
activated pump. Automaticallyactivated pumps which lack automatic
overflow cutoff switches for the
receiving container are prohibited.
(4) Have its surface sloped toward an
area where liquids can be collected for
removal, such as a liquid-tight sump or
a depression, in the case of a single-pour
concrete pad.
(f) For new stationary dry pesticide
containment, what are the specific
design requirements? These are the
specific design requirements for new
stationary dry pesticide containment:
(1) The stationary dry pesticide
containers within the containment unit
must be protected from wind and
precipitation.
(2) Stationary dry pesticide containers
must be placed on pallets or a raised
concrete platform to prevent the
accumulation of water in or under the
pesticide.
(3) The stationary dry pesticide
container storage area must be enclosed
by a minimum of a 6–inch high curb
that extends at least 2 feet beyond the
perimeter of the container.
§ 165.87 Design and capacity
requirements for existing structures.
(a) For all existing containment
structures, what construction materials
must I use? These are the material
specifications for an existing
containment structure:
(1) The containment structure must be
constructed of steel, reinforced concrete
or other rigid material capable of
withstanding the full hydrostatic head,
load and impact of any pesticides,
precipitation, other substances,
equipment and appurtenances placed
within the structure. The structure must
be liquid-tight with cracks, seams and
joints appropriately sealed.
(2) The structure must not be
constructed of natural earthen material,
unfired clay, or asphalt.
(3) The containment structure must be
made of materials compatible with the
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pesticides stored. In this case,
compatible means able to withstand
anticipated exposure to stored or
transferred materials and still provide
secondary containment of those same or
other materials within the containment
area.
(b) For all existing containment
structures, what are the general design
requirements? These are the general
design requirements for existing
containment structures:
(1) You must protect appurtenances
and pesticide containers against damage
from operating personnel and moving
equipment. Means of protection
include, but are not limited to, supports
to prevent sagging, flexible connections,
the use of guard rails, barriers, and
protective cages.
(2) You must seal all appurtenances,
discharge outlets and gravity drains
through the base or wall of the
containment structure, except for direct
interconnections between adjacent
containment structures which meet the
requirements of this subpart.
(3) The containment structure must be
constructed with sufficient freeboard to
contain precipitation and prevent water
and other liquids from seeping into or
flowing onto it from adjacent land or
structures.
(4) Multiple stationary pesticide
containers may be protected within a
single secondary containment unit.
(c) For existing stationary liquid
pesticide containment and existing
containment pads in pesticide
dispensing areas, what are the capacity
requirements? These are the capacity
requirements:
(1) Existing secondary containment
units for stationary liquid pesticide
containers must have a capacity of at
least 100 percent of the volume of the
largest stationary pesticide container
plus the volume displaced by other
containers and appurtenances within
the unit.
(2) Existing containment pads in
pesticide dispensing areas which have a
pesticide container or pesticide-holding
equipment with a volume of 750 gallons
or greater must have a holding capacity
of at least 750 gallons.
(3) Existing containment pads in
pesticide dispensing areas which do not
have a pesticide container or pesticideholding equipment with a volume of at
least 750 gallons must have a holding
capacity of at least 100 percent of the
volume of the largest pesticide container
or pesticide-holding equipment used on
the pad.
(d) For existing stationary liquid
pesticide containment, what are the
specific design requirements? You must
either anchor or elevate each existing
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stationary liquid pesticide container
protected by a secondary containment
unit to prevent flotation in the event
that the secondary containment unit
fills with liquid.
(e) For existing containment pads in
pesticide dispensing areas, what are the
specific design requirements? Each
existing containment pad in a pesticide
dispensing area must:
(1) Be designed and constructed to
intercept leaks and spills of pesticides
which may occur in the pesticide
dispensing area.
(2) Have enough surface area to
extend completely beneath any
container on it, with the exception of
transport vehicles dispensing pesticide
for sale or distribution to a stationary
pesticide container. For such vehicles,
the surface area of the containment pad
must accommodate at least the portion
of the vehicle where the delivery hose
or device couples to the vehicle. This
exception does not apply to transport
vehicles that are used for prolonged
storage or repeated on-site dispensing of
pesticides.
(3) Allow, in conjunction with its
sump, for removal and recovery of
spilled, leaked, or discharged material
and rainfall, such as by a manually
activated pump. Automaticallyactivated pumps which lack automatic
overflow cutoff switches for the
receiving container are prohibited.
(f) For existing stationary dry
pesticide containment, what are the
specific design requirements? These are
the specific design requirements for
existing stationary dry pesticide
containment:
(1) The stationary dry pesticide
containers within the containment unit
must be protected from wind and
precipitation.
(2) Stationary dry pesticide containers
must be placed on pallets or a raised
concrete platform to prevent the
accumulation of water in or under the
pesticide.
(3) The stationary dry pesticide
container storage area must be enclosed
by a minimum of a 6–inch high curb
that extends at least 2 feet beyond the
perimeter of the container.
jlentini on PROD1PC65 with RULES2
§ 165.90 Operational, inspection and
maintenance requirements for all new and
existing containment structures.
(a) What are the operating procedures
required for all new and existing
containment structures? As the owner
or operator of a new or existing
pesticide containment structure, you
must:
(1) Manage the structure in a manner
that prevents pesticides or materials
containing pesticides from escaping
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from the containment structure
(including, but not limited to, pesticide
residues washed off the containment
structure by rainfall or cleaning liquids
used within the structure.)
(2) Ensure that pesticide spills and
leaks on or in any containment structure
are collected and recovered in a manner
that ensures protection of human health
and the environment (including surface
water and ground water) and maximum
practicable recovery of the pesticide
spilled or leaked. Cleanup must occur
no later than the end of each day on
which pesticides have been spilled or
leaked.
(3) Ensure that all materials resulting
from spills and leaks and any materials
containing pesticide residue are
managed according to label instructions
and applicable Federal, State and local
laws and regulations.
(4) Ensure that transfers of pesticides
between containers, or between
containers and transport vehicles are
attended at all times.
(5) Ensure that each lockable valve on
a stationary pesticide container, if it is
required by § 165.45(f), is closed and
locked whenever the facility is
unattended.
(b) What are the inspection and
maintenance requirements for all new
and existing containment structures? As
owner or operator of a new or existing
pesticide containment structure, you
must:
(1) Inspect each stationary pesticide
container and its appurtenances at least
monthly during periods when pesticides
are being stored or dispensed on the
containment structure. Your inspection
must look for visible signs of wetting,
discoloration, blistering, bulging,
corrosion, cracks or other signs of
damage or leakage.
(2) Immediately repair any areas
showing visible signs of damage and
seal any cracks and gaps in the
containment structure or appurtenances
with material compatible with the
pesticide being stored or dispensed.
(3) Not store any pesticide on a
containment structure if the structure
fails to meet the requirements of this
subpart until suitable repairs have been
made. Prompt removal of pesticides,
including emptying of stationary
pesticide containers, in order to effect
repairs or recovery of spilled material is
acceptable.
§ 165.92 What if I need both a containment
pad and a secondary containment unit?
You may combine containment pads
and secondary containment units as an
integrated system provided the
requirements set out in this subpart for
containment pads and secondary
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containment units in §§ 165.85(a) and
(b), 165.87(a) and (b) and § 165.90, and
as applicable, §§ 165.85(c)-(f) and
165.87(c)-(f) are satisfied separately.
§ 165.95 What recordkeeping do I have to
do as a facility owner or operator?
As a facility owner or operator subject
to the requirements of this subpart, you
must maintain the following records,
and you must furnish these records for
inspection and copying upon request by
an employee of EPA or any entity
designated by EPA, such as a State,
another political subdivision or a Tribe:
(a) Records of inspection and
maintenance for each containment
structure and for each stationary
pesticide container and its
appurtenances must be kept for 3 years
and must include the following
information:
(1) Name of the person conducting the
inspection or maintenance;
(2) Date the inspection or
maintenance was conducted;
(3) Conditions noted;
(4) Specific maintenance performed.
(b) Records for any non-stationary
pesticide container designed to hold
undivided quantities of agricultural
pesticides equal to or greater than 500
gallons (1,890 liters) of liquid pesticide
or equal to or greater than 4,000 pounds
(1,818 kilograms) of dry pesticide that
holds pesticide but is not protected by
a secondary containment unit meeting
these regulations must be kept for 3
years. Records on these non-stationary
pesticide containers must include the
time period that the container remains
at the same location.
(c) Records of the construction date of
the containment structure must be kept
for as long as the pesticide containment
structure is in use, and for 3 years
afterwards.
§ 165.97 States with existing containment
programs.
(a) What options are available to
States that already have containment
regulations? States that have
promulgated containment regulations
effective prior to August 16, 2006, and
which also have primary enforcement
responsibility and/or certification
programs, have the option of continuing
to implement their own programs in
lieu of these Federal regulations.
(b) How may a State request authority
to continue implementing its State
containment regulations? A State with
pesticide containment regulations may
request the authority to continue
implementing State containment
regulations by August 16, 2007 in the
following manner:
(1) The State must submit a letter and
any supporting documentation to EPA.
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Supporting documentation must
demonstrate that the States program is
providing environmental protection
equivalent to or more protective than
that expected to be provided by the
Federal regulations in this subpart.
(2) The State must identify any
significant changes to State regulations
which would be necessary in order to
provide environmental protection
equivalent to the EPA regulations, and
develop an estimated timetable to effect
these changes. The letter must be signed
by the designated State Lead Agency.
(c) How will EPA notify the State if its
request is granted? EPA’s Office of
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Pesticide Programs will review the
State’s correspondence and determine
whether the State program is adequate
to provide environmental protection
equivalent to or more protective than
these Federal regulations for new and
existing containment structures. EPA’s
Office of Pesticide Programs will inform
the State of its determination through a
letter authorizing or declining to
authorize the State to continue
implementing its containment
regulations and will detail any reasons
for declining authorization.
(d) How must a State inform EPA of
revisions to its containment regulations?
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Any state that has received
authorization to continue implementing
its state containment regulations must
inform EPA by letter signed by the
designated State Lead Agency within 6
months of any revision to the State’s
containment regulations. EPA will
inform the state by letter if it determines
that the State’s containment regulations
are no longer adequate based on the
revisions. The State’s containment
regulations will remain in effect, unless
and until EPA sends the state a letter
making this determination.
[FR Doc. 06–6856 Filed 8–15–06; 8:45 am]
BILLING CODE 6560–50–S
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| File Type | application/pdf |
| File Title | Document |
| Subject | Extracted Pages |
| Author | U.S. Government Printing Office |
| File Modified | 2006-08-16 |
| File Created | 2006-08-16 |